Drug GMP Warning Letters Spike

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] The number of drug GMP warning letters posted by FDA during December spiked to 26. The 26 drug GMP warning letters were equally divided between the US and ex-US. Pharmacy compounding was the dominant target in the US, with 10 of the 13 issued to compounders – all involving deficient aseptic practices. The other three addressed finished dosage manufacturing – of injectables, ophthalmics, and transdermal patches, respectively. Outside the US, seven warning letters involved dosage manufacturing, four went to API facilities, and two letters went to manufacturers making both. Four of the ex-US letters included data integrity concerns and two addressed limiting inspection access. Another 11 warning letters were posted during the month to nutritional supplement, OTC and cosmetic firms making drug labeling claims, adding drugs to their products without approval, and/or not meeting the dietary supplement GMPs. [A full listing of the drug GMP warning letters issued during December, including a review of the letter’s salient features, is provided on pp. 41-56. The 11 letters referencing labeling, unapproved drugs and dietary supplement GMPs are also listed.]
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