Clinical Specialties Compounding Pharmacy – FDA Warning Letter, Apr 2, 2013

Between March 18 and April 2, 2013, the FDA inspected Clinical Specialties Compounding Pharmacy following reports of five patients developing bacterial endophthalmitis linked to two lots of Avastin repackaged by the firm. The firm voluntarily recalled all Avastin unit dose syringes on March 15, 2013, and expanded the recall on March 20, 2013, to include all sterile products produced and distributed since October 19, 2012, due to lack of sterility assurance.

The FDA found the firm's drug products, intended to be sterile, were prepared, packed, or held under insanitary conditions, rendering them adulterated under section 501(a)(2)(A) of the FDCA. Observed violations included poor aseptic practices, specifically the failure to use a sporicidal agent in the clean room and ISO-5 area disinfection program, and not sanitizing equipment or supplies before placement into the ISO-5 area. These failures expose products to contamination.

In response to the FDA-483, the firm stated it permanently discontinued sterile drug production effective March 8, 2013, and does not intend to resume. The firm committed to implementing corrective and preventative actions based on relevant guidelines. The FDA requires written notification within fifteen working days regarding steps taken to address insanitary conditions or confirmation of not resuming sterile drug production. If sterile operations resume,