FDA WARNING_LETTER - Americare Compounding, LLC. - June 19, 2013

On April 22, 2014, the FDA issued a Warning Letter to Americare Compounding, LLC, following an inspection from June 3-19, 2013. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients, violating the Federal Food, Drug, and Cosmetic Act (FDCA) and the Compounding Quality Act (CQA). These drugs are considered misbranded under section 502(f)(1) of the FDCA.

Additionally, serious deficiencies in sterile drug product manufacturing were observed, rendering all sterile products adulterated under section 501(a)(2)(A) of the FDCA. Violations included operators reusing gowns for a week, failure to use sporicidal disinfectants in the cleanroom, and lack of studies to ensure adequate protection of the ISO 5 area. For drugs compounded without individual prescriptions, the firm is subject to Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), and significant CGMP violations were noted, causing these products to be adulterated under section 501(a)(2)(B).

Specific CGMP violations included failure to establish procedures to prevent microbiological contamination, inadequate personnel clothing, insufficient facility design to prevent contamination, inadequate environmental monitoring, poor cleaning/disinfection systems, lack of final product conformance testing for sterile products, and absence of stability testing programs.