FDA warning letters detail violations at China, Mexico drugmakers already under import alert
Shoddy manufacturing practices triggered FDA warning letters for a pair of foreign producers of over-the-counter drugs.
Dibar of Mexico, a CDMO for nutritional and self-care products, and Foshan Biours Biosciences of China, which specializes in gel patches, were cited for failure to fix problems the FDA raised in April of last year.
Both letters were dated March 10 and posted on the FDA website Wednesday. The companies have been barred from importing their products to the U.S. since last fall.
The Dibar plant in Morelia, Michoacan, four hours west of Mexico City, failed to adequately test the identity of incoming components used to produce drugs, conducting only random tests and identification by sensory evaluation. It also failed to determine the identity and strength of finished products bound for the U.S.
Dibar also failed to provide evidence of a program to test product stability and guarantee expiration dates. In addition, Dibar did not show its manufacturing equipment was appropriate for its operations, or for cleaning and maintenance.
The Foshan plant, on the outskirts of Guangzhou, was cited for similar concerns, failing to adequately test finished products, ensure their stability to determine appropriate storage conditions and expiration dates and to follow procedures for cleaning and maintenance of equipment.
The FDA recommended both companies hire consultants to audit their operations for compliance.
The FDA put all drug products manufactured by Dibar and Foshan on import alert last fall, and the companies will remain on the list until they show the problems are fixed. The companies have 15 working days to respond with evidence of compliance or a plan to do so.