Skip to content

#监管审批

Today 0 items
Oct 15Thu
  1. ema.europa.eu90

    EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

    EMA's CHMP has recommended EU marketing authorisation for Revolution Medicines' Rasonque (daraxonrasib), an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma previously treated at least once. In a 500-patient phase 3 study, median overall survival was 12.4 months versus 6.7 with chemotherapy, and median progression-free survival 7.2 versus 3.6 months. The European Commission will now fast-track its decision, with pricing left to Member States.

    Why it matters: CHMP backing via a phased review under 150 days sets precedent for faster EU assessments of priority cancer medicines.

Oct 14Wed
  1. fda.gov91

    FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

    The FDA expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer, the first FDA-approved treatment for that disease. The decision relied on evidence from Anktiva's earlier approval for carcinoma in situ, where a trial showed a majority of adults achieved a complete response and many maintained it for at least 12 months. The FDA is finalizing draft guidance to let developers use CIS study evidence for papillary-only NMIBC approvals.

    Why it matters: FDA extends Anktiva to BCG-unresponsive papillary-only NMIBC and sets a precedent for cross-indication evidence use.

  2. fda.gov76

    FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

    On October 14, 2026, the FDA expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, an ImmunityBio subsidiary) with BCG to cover adults with BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors, beyond the prior indication limited to carcinoma in situ. The agency extrapolated efficacy from Cohort A of QUILT-3.032, a single-arm trial of 77 patients, which showed a complete response rate of 62%. The recommended dose is 400 mcg intravesically with BCG weekly for 6 weeks induction, followed by maintenance for up to 37 months.

  3. fda.gov45

    Jiangmen Shuizirun Sanitary Articles Co., Ltd. - 722974 - 09/23/2026

    FDA issued a warning letter, reference 320-26-130, to Jiangmen Shuizirun Sanitary Articles Co., Ltd. of Guangdong, China, after a November 3 to 7, 2025 inspection of its drug manufacturing facility documented CGMP violations for finished pharmaceuticals. The firm, whose OTC products are labeled sterile but not sterilized and lack sterility testing at release, also failed to conduct identity testing on incoming components and to validate supplier certificates of analysis. The letter, sent September 23, 2026, asks for an action plan covering customer notifications, recalls or market withdrawals for sterile-labeled batches in U.S. distribution.

  4. fda.gov55

    Hanlim Pharm Co., Ltd. - 734782 - 10/02/2026

    FDA issued a warning letter, reference 320-27-03, to Hanlim Pharm Chairman Jungjin Kim on October 2, 2026, citing significant CGMP violations at the company's sterile drug manufacturing facility in Yonginsi, Gyeonggi-do, inspected from April 16 to April 24, 2026. The letter details poor aseptic practices, inadequate smoke studies and cleanroom design flaws risking product sterility, and calls the company's May 15, 2026 response inadequate. Hanlim must now submit a systematic plan covering aseptic practices, cleanroom behavior and independent assessments, or face seizure or injunction.

    Why it matters: FDA warning letter over CGMP violations at a sterile drug manufacturing site affects Hanlim Pharm's US supply prospects.

  5. fda.gov51

    Eurofins SF Analytical Laboratories, Inc. - 736056 - 10/06/2026

    FDA issued a warning letter dated October 6, 2026 to Eurofins SF Analytical Laboratories, a contract testing laboratory in Horsham, Pennsylvania, after a June 1-3, 2026 inspection documented CGMP violations under 21 CFR parts 210 and 211. FDA found analysts selectively omitted too-numerous-to-count results, recorded counts from cracked and desiccated plates, and lacked secondary verification of zero-CFU readings; the firm admitted inconsistent reporting practices dating back to February 2025. FDA deemed the firm's June 22, 2026 response inadequate and demanded an independent laboratory assessment, a remediation plan, and a CAPA plan, warning that failure to comply may bring seizure or injunction.

  6. fda.gov49

    Silgan Dispensing Systems - 734538 - 10/05/2026

    FDA issued a warning letter dated October 5, 2026, to Earl Lawson, president of Silgan Dispensing Systems, after a March 26 to April 2, 2026 inspection of the Silgan Unicep Packaging facility in Spokane, Washington, which contract manufactures non-sterile over-the-counter drug products. FDA cited CGMP violations including invalidated out-of-specification microbiological results obtained through averaging, an inadequate investigation linked to a customer's Class I recall over potential fungal contamination, and unapproved new drug claims found in product labeling reviewed in July 2026. FDA reviewed the firm's April 22, 2026 response and warned that failure to correct the violations may result in seizure or injunction.

  7. fda.gov49

    Lovelace Biomedical Research Institute - 725136 - 10/06/2026

    FDA issued a Warning Letter to Lovelace Biomedical Research Institute in Albuquerque, citing Good Laboratory Practice violations found during an April 7-18, 2025 inspection under the Bioresearch Monitoring Program. The quality assurance unit failed to review final study reports so that results reflected raw data, omitting abnormal clinical observations in 20 of 34 animals in one protocol and dosing incidents such as pulled catheters and infiltration at the infusion site. FDA found the May 9, 2025 written response and the revised reports dated May 30, 2025 inadequate.

  8. fda.gov50

    SCA Pharmaceuticals, LLC - 724202 - 09/14/2026

    FDA issued a warning letter to SCA Pharmaceuticals, LLC, a 503B outsourcing facility in Little Rock, Arkansas, on September 14, 2026, following an inspection from October 20 to 30, 2025 that found sterile drug products prepared under insanitary conditions. Cited deficiencies include inadequate ISO 5 certification, poor response to microbial contamination, and aseptic technique failures during production of lots such as Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% and Methadone HCl 10 mg/mL. FDA reviewed the firm's responses of November 21 and December 31, 2025, and deemed the products adulterated under section 501(a)(2)(A) of the FDCA.

Oct 10Sat
  1. fda.gov87

    FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus

    FDA has approved Hovilpri (pritelivir) tablets for immunocompromised adults with mucocutaneous herpes simplex virus lesions who did not respond to acyclovir, valacyclovir or famciclovir. In the Phase 3 PRIOH-1 Part C trial of 101 adults, all lesions healed within 28 days in 63% of pritelivir patients versus 34% on investigator-chosen treatments. The drug received priority review, and headache was the most common adverse reaction.

    Why it matters: First approval of a new mechanism option for immunocompromised HSV patients resistant or intolerant to existing antivirals.

  2. fda.gov40

    Novel Drug Approvals for 2026

    The FDA's novel drug approvals page for 2026 lists 46 approvals to date, from relacorilant for platinum-resistant ovarian cancer on 3/25 through pritelivir for refractory mucocutaneous herpes simplex lesions in immunocompromised adults on 10/9. The list spans oncology, rare disease, metabolic and imaging agents, including orforglipron for obesity, tulisokibart for ulcerative colitis, and two FOP drugs, zilurgisertib and garetosmab. The list is updated as further approvals are granted.

Oct 9Fri
  1. fda.gov49

    Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers

    The FDA has issued a final guidance for industry, "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers," from its drug and biologics centers. It answers common questions on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products licensed under the PHS Act. The guidance finalizes a draft of the same title issued on July 23, 2024, under docket FDA-2024-D-2581, and comments may be submitted at any time.

  2. fda.gov93

    FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

    The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

    Why it matters: FDA approval of atezolizumab plus chemotherapy as adjuvant therapy for Stage III dMMR colon cancer, with a disease-free survival hazard ratio of 0.50.

Oct 8Thu
  1. fda.gov80

    FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer

    The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.

    Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.

  2. fda.gov55

    Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing

    The FDA's Center for Drug Evaluation and Research issued a draft guidance on studying pharmacokinetics, and where appropriate pharmacodynamics, in patients with impaired hepatic function, including for therapeutic biological products. The non-binding recommendations cover study design, data analysis and impact on dosing for sponsors and applicants. Comments are due by 12/01/2026 under docket FDA-2026-D-8693 before work begins on the final version.

    Why it matters: Draft FDA guidance sets expectations for hepatic impairment PK studies that shape sponsors' clinical development plans.

Oct 7Wed
  1. fda.gov40

    Rare Disease Drug Approvals

    FDA's CDER lists recent rare disease drug approvals on its Accelerating Rare Disease Cures Program page. In 2026 alone these include Camzyos for an inherited heart condition in children, Emcitate for MCT8 deficiency, Isembyld for muscle loss in spinal muscular atrophy, and Zanvastro for Alexander Disease, among others. The list spans 2021 to 2026 and links to the underlying FDA news releases.

Oct 6Tue
  1. fda.gov44

    Online Generic Medicine/www.onlinegenericmedicine.com - 737806 - 09/23/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated September 23, 2026 to Online Generic Medicine (www.onlinegenericmedicine.com) for selling unapproved and misbranded injectable semaglutide, including a product marketed as "Semanat Injection (Semaglutide)". The letter cites violations of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1) and 505(a) of the FD&C Act, identified in website reviews on August 26 and September 2, 2026. FDA asks the site to stop offering unapproved and misbranded drugs to U.S. consumers and warns that failure to comply may bring seizure or injunction.

  2. fda.gov46

    TCI Co., Ltd BioCosme PABP BRANCH - 736888 - 09/02/2026

    FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH, a contract manufacturer of over-the-counter drugs in Pingtung County, Taiwan, citing significant CGMP violations found during an inspection from March 9 to 13, 2026. The firm released OTC drug batches to the U.S. market without assay testing of the active ingredient and failed to perform identity testing on incoming APIs and raw materials or verify supplier certificates of analysis. FDA found the firm's April 2, 2026 response to its Form FDA 483 inadequate and required a comprehensive quality agreement and lists of test methods and specifications; failure to correct the violations may bring regulatory action without further notice.

    Why it matters: FDA warning letter documents CGMP failures at an OTC contract manufacturer supplying the U.S. market.

  3. fda.gov46

    Pine Pharmaceuticals, LLC - 728537 - 08/07/2026

    FDA issued a warning letter dated August 7, 2026 to Pine Pharmaceuticals, LLC, a section 503B outsourcing facility in Tonawanda, New York, after a November 4-14, 2025 inspection found insanitary conditions and CGMP violations that rendered sterile drug products adulterated. Cited failures include inadequate disinfection of materials entering the ISO 5 hood, deficient environmental monitoring of staging trays, and incomplete batch failure investigations. The letter follows the firm's December 8, 2025 response to a Form FDA 483, and FDA expects corrective action.

  4. fda.gov55

    Walmart, Inc. - 736557 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter dated October 1, 2026 to Walmart President and CEO John Furner over three products sold on walmart.com: HClear for him, Herstat GST, and Terragen HG Formula. Purchased by FDA in July 2026 and shipped via Walmart Fulfillment Services, the products are marketed for genital herpes and genital sore symptoms and are unapproved new drugs under section 505(a) of the FD&C Act. FDA notes no OTC drug product is approved for treating any STI and warns that failure to correct the violations may bring seizure or injunction without further notice.

    Why it matters: FDA targets a major retailer for selling unapproved STI products, a direct compliance risk for online drug marketplaces.

  5. fda.gov41

    Aidance Scientific, Inc. - 735346 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter dated October 1, 2026 to Aidance Scientific, Inc. president Perry Antelman, citing the company's "Terragen HG Formula" as an unapproved new drug sold via its website and Amazon storefront for herpes and genital sores. The agency found no approved application for the product and warned that OTC products marketed for STIs pose public health risks, noting homeopathic drugs face the same approval requirements. Failure to correct the violations may prompt seizure or injunction.

  6. fda.gov42

    The Platinum Healthcare LLC - 735147 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter on October 1, 2026 to The Platinum Healthcare LLC and its CEO Jamey Hagan of Pulaski, Tennessee, over products sold on its website. The agency found the homeopathic products "Sycosis" and "Syphillinum," marketed for gonorrhea and syphilis miasms, to be unapproved new drugs violating sections 301(d) and 505(a) of the FD&C Act, noting no OTC product is approved for treating STIs. The company must send a written response to FDA within fifteen business days or face possible seizure and injunction.

  7. fda.gov45

    DesBio/Deseret Biologicals, Inc. - 735464 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 (reference 735464) to DesBio/Deseret Biologicals CEO Jake Carter, citing the product "CHLA:10M," sold on desbio.com for relief of chlamydia-related symptoms, as an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act. The letter follows a website review in July 2026 and notes that FDA has not approved any OTC drug product for treating or preventing any STI. The company must send a written response to FDAAdvisory@fda.hhs.gov within 15 business days or face possible seizure or injunction.

  8. fda.gov45

    Bioactive Services USA, LLC / Herstat Inc. - 734784 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter on October 1, 2026 to Kevin Aspinall Nessling, CEO of Bioactive Services USA, LLC / Herstat Inc., over the product "Herstat GST", marketed for genital sore treatment on the websites drsosnowski.com and herstat.com. FDA found the product is an unapproved new drug under section 505(a) of the FD&C Act, based on a July 2026 review of the websites and the firm's Facebook and Instagram accounts. FDA notes it has not approved any OTC drug for treating or preventing STIs, and warned that failure to correct the violations may result in seizure or injunction.

  9. fda.gov56

    Amazon.com, Inc. - 736006 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 (reference 736006) to Amazon CEO Andy Jassy, citing nine products sold on amazon.com and fulfilled via Fulfillment by Amazon, including FemiClear, HClear for him, HerpCare Ointment and Spray, and RoyceDerm Herpes Relief Cream, as unapproved new drugs for genital herpes under section 505(a) of the FD&C Act. FDA, which purchased the products in July 2026, notes no OTC drug is approved for treating any STI and warns that reliance may delay care and risk infertility, sepsis and death. Amazon must correct the violations or face regulatory or legal action including seizure and injunction.

    Why it matters: FDA warning letter puts Amazon's marketplace and Fulfillment by Amazon service directly in the regulatory line for unapproved STI drugs.

  10. fda.gov45

    OrganiCare, LLC / OrganiCare Nature’s Science, LLC - 734925 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 to Caroline Goodner, CEO of OrganiCare, LLC / OrganiCare Nature's Science, LLC, after a July 2026 review of the femiclear.com website and the company's Facebook and Instagram accounts. The letter states that "HClear for him" and "FemiClear Genital Herpes Symptoms" are unapproved new drugs under section 505(a) of the FD&C Act, marketed without any FDA-approved OTC product for treating STIs. FDA warns that failure to correct the violations may result in seizure and injunction without further notice.

  11. fda.gov40

    Rare Disease News & Events

    The FDA's ARC Program reviewed its 2025 rare disease work, reporting more than 30 public speaking engagements, 57-plus workshops, consults or meetings supporting rare disease drug development, and 45,000 rare disease news subscribers served. CDER approved 46 novel drugs in 2025, with 32 approved first in the U.S. and 23 carrying orphan drug designation. In FY25 the Office of Orphan Products Development granted 450 of 657 original orphan-drug designation requests, and public workshops on rare disease data sharing and neonatal product development are scheduled or archived for 2026.

  12. fda.gov47

    Glenmark Pharmaceuticals Limited - 637314 - 11/22/2022

    The FDA issued a warning letter to Glenmark Pharmaceuticals on November 22, 2022, after inspecting its finished-drug manufacturing facility in Colvale, Goa, from May 12 to May 20, 2022, and finding significant CGMP violations. The letter cites inadequate investigation of out-of-specification results, including 14 rejected batches of desmopressin acetate tablets from 2018 to 2021 and a June 10, 2022 voluntary recall of batch 20220121, plus insufficient process validation for a gel product with five batches rejected for viscosity failures between 2020 and 2021. Glenmark must respond with independent assessments and remediation plans for its investigation and CAPA systems and its process validation program.

  13. fda.gov64

    M15 Resource Center

    The FDA has posted a resource center for ICH M15, a guidance on general principles for model-informed drug development (MIDD). The guidance describes MIDD principles, including planning, model evaluation and evidence documentation, sets a harmonized framework for assessing MIDD-derived evidence, and gives recommendations on MIDD-related regulatory interactions, reporting and submission. FDA recommends sponsors use it when preparing meeting requests, background packages and regulatory submissions.

    Why it matters: FDA now expects ICH M15 principles to shape MIDD evidence in submissions and meetings.

  14. fda.gov54

    Expedited Investigational New Drug Pilot Program - Application Instructions

    The FDA has issued application instructions for its Expedited IND Pilot Program. Sponsors and prospective Qualified Research Institutions each complete a form, then the sponsor submits both through the FDA ESG Gateway as one package. The application window stays open for 45 days with possible extension, and FDA scientific experts will review submissions and select 8 to 10 Sponsor-QRI pairs. Participating parties must form their business relationship outside FDA, which will only confirm that an official agreement exists.

    Why it matters: FDA sets out how sponsors and QRIs apply for the Expedited IND Pilot Program and how many pairs will be selected.

Oct 3Sat
  1. fda.gov74

    FDA approves pirtobrutinib for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma

    FDA approved Eli Lilly's pirtobrutinib (Jaypirca) on October 2, 2026 for adults with previously untreated CLL or SLL without 17p deletion. In the BRUIN CLL-313 trial of 282 patients randomized to pirtobrutinib or bendamustine plus rituximab, median PFS was not estimable with pirtobrutinib versus 33.5 months in the control arm (hazard ratio 0.20, p<0.0001) at a median follow-up of 28 months. The recommended dose is 200 mg orally once daily until progression or unacceptable toxicity.

    Why it matters: FDA approval of pirtobrutinib moves the BTK inhibitor into first-line CLL/SLL treatment based on a 0.20 hazard ratio.

  2. fda.gov50

    Oncology (Cancer)/Hematologic Malignancies Approval Notifications

    The FDA issued a run of oncology and hematology approvals from July 31 to October 2, 2026. They include pirtobrutinib (Jaypirca, Eli Lilly) for previously untreated CLL or SLL without 17p deletion on October 2, belzutifan plus lenvatinib for advanced clear-cell renal cell carcinoma on September 24, lirafugratinib (Lyrfigtu, Elevar) for FGFR2-rearranged cholangiocarcinoma on September 23, imlunestrant plus abemaciclib for ESR1-mutated breast cancer on September 18, and daraxonrasib (RASONQUE, Revolution Medicines) for metastatic pancreatic adenocarcinoma on August 26. Accelerated approvals in the batch cover sevabertinib for HER2-mutated NSCLC, camizestrant for ESR1-mutated breast cancer, iberdomide for multiple myeloma, and vusolimogene oderparepvec plus nivolumab for melanoma.

Oct 2Fri
  1. fda.gov54

    FDA Approves First Heart Valve Designed to Grow with Children

    The FDA approved the Autus Size-Adjustable Valve, developed by Autus Valve Technologies and approved via Edwards Lifesciences, for pediatric patients with congenital pulmonary valve disease. It is the first heart valve that can be expanded after implantation, growing from about 13 millimeters to up to 22 millimeters, and the first U.S.-approved valve with polymeric rather than animal-derived leaflets. Approval rests on a study of 62 pediatric patients at 12 U.S. sites, with no deaths or clot-related complications; longer-term studies are under way.

    Why it matters: First FDA-approved expandable pediatric heart valve may cut repeat open-heart surgeries in children.

Oct 1Thu
  1. fda.gov51

    FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

    The FDA is warning patients and health care professionals about risks from unapproved compounded versions of GLP-1 drugs, including semaglutide and tirzepatide, used for weight loss, because these products are not reviewed for safety, effectiveness or quality. The agency states that retatrutide and cagrilintide cannot be used in compounding under federal law, has warned telehealth companies, API distributors and outsourcing facilities over retatrutide, and set up import alert 66-80 to stop GLP-1 APIs with quality concerns at the border. It also advises discarding multi-dose vials within 28 days of first use and not using injectable GLP-1 drugs that arrive warm.

  2. fda.gov63

    Fresenius Kabi USA LLC - 733107 - 09/22/2026

    FDA issued a warning letter, reference 320-26-129, to Fresenius Kabi USA CEO Pierluigi Antonelli on September 22, 2026, citing CGMP violations found at its sterile injectable manufacturing facility in Melrose Park, Illinois, inspected from January 27 to February 18, 2026. FDA says the firm failed to adequately investigate drug product failures, including bioburden action limit failures linked to adverse events with famotidine for injection, leading to a recall of three famotidine injection batches after an endotoxin failure in retained samples. FDA found the company's March 11, 2026 response inadequate and warned that failure to correct violations may result in seizure or injunction.

    Why it matters: FDA warning letter over CGMP failures at a major sterile injectables plant, with a famotidine recall tied to adverse events.

  3. fda.gov61

    FDA approves first drug to improve functional capacity and symptoms in children with rare inherited heart condition

    The FDA approved Camzyos (mavacamten) as the first treatment to improve functional capacity and symptoms in children with symptomatic obstructive hypertrophic cardiomyopathy, extending approval to pediatric patients weighing at least 30 kg, after adult approval in 2022. Efficacy was supported by the phase 3 SCOUT-HCM trial in 44 patients aged 12-18, where once-daily dosing for 28 weeks significantly reduced the Valsalva LVOT gradient versus placebo. The drug carries a boxed warning for heart failure risk and is available only through the Camzyos REMS program.

    Why it matters: First pediatric approval for symptomatic oHCM, backed by phase 3 data in adolescents.

Sep 30Wed
  1. fda.gov66

    Fresenius Kabi AG - 733107 - 09/22/2026

    FDA issued a warning letter to Fresenius Kabi AG CEO Pierluigi Antonelli on September 22, 2026, citing CGMP violations found during an inspection of Fresenius Kabi USA's sterile injectable plant in Melrose Park, Illinois, from January 27 to February 18, 2026. Violations include inadequate investigations of endotoxin test failures tied to adverse events with famotidine for injection, leading to a recall of three batches, and repeated media fill failures on aseptic lines in 2024 and 2025. FDA found the firm's March 11, 2026 response inadequate and warned that failure to correct the violations could bring seizure or injunction.

    Why it matters: FDA warning letter details unresolved CGMP failures at a major sterile injectables maker after a drug recall.

Sep 29Tue
  1. fda.gov47

    VeganicSKN Limited - 719883 - 02/09/2026

    FDA issued Warning Letter 320-26-44 to VeganicSKN Limited, a drug manufacturer in Rocklea, Queensland, Australia, following an inspection from July 15 to 21, 2025, citing significant CGMP violations that render its drug products adulterated. The letter cites an out-of-specification investigation opened on December 4, 2024, after a contract lab reported a failing result on August 28, 2024, with the batch still released and shipped to the U.S. market and the investigation closed on July 11, 2025 without a root cause. FDA found the August 11, 2025 response inadequate and requires a retrospective review of invalidated OOS results plus a CAPA and remediation plan for its testing and supplier-verification systems.

    Why it matters: FDA warning letter details CGMP failures at a foreign supplier of drugs to the U.S. market.

  2. fda.gov45

    Curia New York, Inc. - 728790 - 09/18/2026

    The FDA issued a warning letter, reference 320-26-127 dated September 18, 2026, to Curia New York, Inc. CEO Philip Macnabb after a January 28 to February 5, 2026 inspection of its API manufacturing facility in Rensselaer, New York, found CGMP deviations. Analysts performed thousands of unexplained HPLC and UPLC trial injections over 30 months using Empower, over 70 in October 2025 alone via TotalChrom, and about 20 percent of Empower trial injections were acquired or altered in "Developer" mode. The FDA found the firm's February 27, 2026 response inadequate and requires a comprehensive independent investigation of all trial injections.

    Why it matters: FDA warning letter details unresolved data-integrity failures at an API maker supplying the industry.

  3. fda.gov41

    Kellin Chemicals Co., Ltd. - 716228 - Zhangjiagang

    FDA issued a warning letter dated November 6, 2025 to Kellin Chemicals (Zhangjiagang) Co., Ltd., a China-based API supplier, after the firm refused a pre-announced inspection scheduled for July 7 to July 11, 2025. FDA deems its drugs adulterated under section 501(j) of the FD&C Act, may withhold approval of applications listing the firm as a manufacturer, and may detain or refuse shipments into the U.S. The company must respond in writing within 15 working days and may request an FDA inspection.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org