FDA 483 - MOORE'S PHARMACY INC - September 01, 2016

The FDA Form 483 details significant deficiencies at a drug manufacturing facility. The building itself was not maintained in a clean and sanitary condition, with a large dead cockroach observed in the drug production room, and both live and dead pests in the pharmacy where capsules are stored. Structural issues included a 1x1 foot hole in the roof of the production room exposing insulation and an uncontrolled warehouse, and gaps of 1 inch and 0.5 inches under production room doors, allowing pest entry.

The firm failed to conduct potency testing of non-sterile finished products, despite routinely assigning 180-day Beyond Use Dates (BUDs). From 7/25/2015 to 7/13/2016, no finished products were sent for testing. In-process control procedures were deficient, lacking examination of mixing adequacy for uniformity and homogeneity, particularly for progesterone-containing capsules. Formula worksheets did not clearly indicate how pharmacists could verify correct mixing.

Finished product testing from 12/17/2014 to 8/26/2016 showed 70% of tested lots had out-of-specification potency results (sub- or super-potent), with examples including Estrone at 134% and Estriol at 56.7% of expected levels. No investigations, CAPAs, or recalls were performed for these failures, and customers were not notified of issues with sub