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Foreign Inspections by FDA

The US General Accounting Office (GAO) criticised what it concluded is a lack of FDA inspection of foreign API and finished dosage form manufacturers.  This has received a lot of coverage in the lay and professional press, especially since a huge increase in API’s is coming from China; FDA has only 13 inspections scheduled in China, a country with over 700 drug manufacturers.

Camargo’s experience with sourcing API’s in China has not been good.  Due to quality concerns we greatly expanded the scope of testing attributes.  We found benzene (a carcinogen) in startling amounts in one API lot.  After investigation, we learned that the Chinese drug manufacturer had recently been a paint manufacturer and had cleaned all the vessels and pipe with benzene.

However, our efforts show that US manufacturers don’t rely on the FDA to assure safety of pharmaceuticals.  As Bruce Downey, CEO of Barr Laboratories and head of the Generic Pharmaceutical Association, testified at a congressional hearing,  that US drug firms inspect suppliers  and perform extensive product testing.

Moreover, FDA does extensive checking before product approval and reviews all changes in sources through the DMF (Drug Mater File) system.  The DMF is a record of the manufacturing process, quality and stability of every ingredient and packaging material.

Reference: The current FDA Guide to Foreign Inspections