FDA’s FY 2013 Drug GMP Warning Letters

Topicals and injectables were the most common types of products to receive drug GMP warning letters in FY 2013. All 43 warning letters are listed here by dosage form with the key issues described.

The following is a list of 43 cGMP warning letters issued to drug manufacturers, biologics manufacturers, testing laboratories, cosmetics manufacturers, compounding pharmacies and repackagers during the fiscal year that ended Sept. 30, 2013. The warning letters are categorized according to the type of drug product involved (topical, active ingredients, injectable, oral solid, oral liquid, therapeutic biologic and miscellaneous). Warning letters that target two types of products, such as APIs and solid oral dosage forms, went into the miscellaneous category and are counted once. The listing provides the recipient’s name, the location of the inspected facility, the date the warning letter was issued and the date of the inspection, followed by a description of the GMP area(s) addressed in the letter.

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