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The FDA hit OTC drug manufacturer NeoBiotech Global of Auburn, Washington with a Form 483 for operating without a quality control unit and other serious violations. Read More
The FDA’s Office of Prescription Drug Promotion issued a warning letter to Metuchen Pharma over misleading claims in a print advertisement for its erectile dysfunction drug Stendra (avanafil). Read More
The FDA hit TG United’s drug manufacturing facility north of Tampa, Florida with a warning letter for repeat water system and cleaning failures found during a lengthy inspection. Read More
Acting FDA Commissioner Ned Sharpless flagged the agency’s increased focus on data integrity violations — and a warning letter sent Tuesday to a Chinese OTC drugmaker over falsified quality control documents. Read More
The FDA found “moldlike” growth and other contaminants at Kumho Dental Pharmaceutical’s over-the-counter dental drug facility in Seoul, South Korea. Read More