FDA cites Rohto Pharmaceutical's Vietnam plant for falsified records
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On October 14, 2026, the FDA sent Rohto Pharmaceutical a warning letter over its Vietnam manufacturing plant (FEI 3008808745), citing systematic falsification of environmental monitoring, personnel monitoring, and cleaning records. The agency found deficiencies in aseptic process controls that led to roughly 25 excursions beyond ISO 5 limits. Separately, the letter states that seven ROHTO Cooling Eye Drops products are unapproved new drugs, and that their labeling misleadingly claims FDA endorsement. The warning letter is public, and the company's response and any resulting regulatory or enforcement action, including possible import restrictions or product removal, remain open questions.
Written by a model from the reports · updated 4 hours ago
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- U.S. FDARohto Pharmaceutical Co., Ltd. - 733215 - 10/14/2026
On October 14, 2026, the FDA sent Rohto Pharmaceutical a warning letter citing its Vietnam facility (FEI 3008808745) for systematic falsification of environmental monitoring, personnel monitoring, and cleaning records, along with aseptic process deficiencies that produced about 25 ISO 5 exceedances. The letter also states that seven ROHTO® Cooling Eye Drops products are unapproved new drugs with labeling that misleadingly claims FDA endorsement.
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