CGMP Deviations at Apotheca Supply

A 2/10-12/15 FDA inspection at Apotheca Supply, a Decatur, AL, pharmaceutical manufacturing (repackaging and relabeling) facility found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients, according to a just-released Warning Letter from the agency’s New Orleans District Office. Specific violations included: 

•          failure of the firm’s quality unit to review and approve all quality related documents and failure to have the quality unit’s main responsibilities described in writing;
•          failure to have stability data to support the extension of expiration dates;
•          failure to ensure the cleanliness of the firm’s facility and equipment.

 The letter says the firm’s response lacked sufficient corrective action. Apotheca was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.