The FDA issued a warning letter to Ami Cosmetics in Soeul, South Korea, saying the over-the-counter drugmaker had contradictory information in its labeling and its electronic listing in the FDA’s National Drug Code directory. Read More
The FDA cited Reliance Life Sciences for a long list of deficiencies observed during an inspection of the API manufacturer’s facility in Navi Mumbai in December. Read More
The FDA cited Arcamed for deficiencies in its CAPA procedures and issues with its quality audit and employee training procedures after a February/March inspection of the company’s Indianapolis facility. Read More
The FDA slapped Gendron with a Form 483 for shoddy complaint handling and deficient MDR procedures, as well as issues with its internal quality auditing. Read More
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