FDA EIR - Metro Drugs 3rd Ave. Corp. - April 05, 2019

An FDA inspection of Metro Drugs 3rd Ave Corp (doing business as Metro Integrative Pharmacy) in New York, NY, was conducted from February 5 to March 1, 2019. The inspection, initiated as a high-priority "for cause" assessment under CPGM 7356.002A, aimed to evaluate the compounding pharmacy's sterile and non-sterile drug production practices and facility conditions, and to follow up on complaints regarding "essentially a copy" drug products. The inspection revealed several significant issues, resulting in a five-item FDA Form 483, Inspectional Observations, and seven additional verbal observations. Key violations included the use of non-sterile wipes in ISO 5 aseptic processing areas, release of drug products with incorrect strength, purity, or quality, and failure to perform media fills that accurately simulate aseptic production. Furthermore, ISO 7 cleanroom areas were only certified under static conditions, not dynamic, and inadequate air pressure differentials were noted. Verbal observations highlighted improper cleaning and disinfection of aseptic hoods and the use of bulk drug substances not compliant with Section 503A of the FDC Act, such as rose geranium oil and collagen hydrolysate powder. The firm's management committed to providing a written response to the FDA 483 observations and the bulk drug substance violations within 15 business days following the inspection's conclusion.