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

On September 1, 2016, the FDA issued a Form FDA 483 to Moore's Pharmacy, Inc. following an inspection from August 25 to September 1, 2016. The inspection revealed that drug products produced by Moore's Pharmacy, Inc. failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically regarding the requirement for valid prescriptions for individually-identified patients. This failure means the compounded drug products are not exempt from FDA approval, adequate labeling, and current good manufacturing practices (CGMP).

The FDA investigator observed insanitary conditions, including a dead cockroach in the drug production room, a hole in the ceiling exposing insulation, and gaps under doors leading to an uncontrolled warehouse. These conditions render the drug products adulterated under section 501(a)(2)(A) of the FDCA. Additionally, significant CGMP violations were noted, including failure to maintain clean and sanitary buildings free of vermin (21 CFR 211.56(a)), failure to investigate discrepancies (21 CFR 211.192), and failure to ensure expiration dates were supported by stability testing (21 CFR 211.137(a)). The ineligible drug products are also considered misbranded under section 502(f)(1) of the FDCA due to inadequate directions for use