U.S. FDA· FDA·· 4 hours agoScore54
Rohto Pharmaceutical Co., Ltd. - 733215 - 10/14/2026
In brief
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.
Source: U.S. FDA