Enforcement Log, Dateline 08.25.16: College Pharmacy, Frontida BioPharm, Unimark, Huzhou Aupower, Cape Apothecary, Hospira

Sterility assurance concerns and evidence of microbial contamination predominated in enforcement actions disclosed during the past week, including FDA warning letters, import alerts and EU GMP suspensions. But basic GMP failures were also an issue at some sites.

Compounding pharmacy College Pharmacy's manufacture and distribution of some products without valid prescriptions for individually identified patients drew an FDA citation under two Food, Drug and Cosmetic Act provisions for continued objectionable conditions in its aseptic processing operations, the agency said in an Aug. 15 warning letter.

FDA cited the Colorado Springs, Colo., pharmacy for adulteration of purportedly sterile drugs under section 501(a)(2)(A) of the act, but...

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