FDA WARNING_LETTER - Grandpa's Compounding Pharmacy, Inc. - September 10, 2013

An FDA inspection of Grandpa's Compounding Pharmacy, Inc. from September 3-10, 2013, revealed serious violations. The firm was found to be producing drug products without valid prescriptions for individually-identified patients, rendering them misbranded under FDCA section 502(f)(1). Additionally, investigators observed critical deficiencies in sterile drug product manufacturing, including insanitary conditions such as duct-taped air supply ductwork, an in-wall air conditioner in the cleanroom, operators with exposed skin during aseptic manipulations, and the use of tap water for cleaning injectable containers. These conditions caused sterile products to be adulterated under FDCA section 501(a)(2)(A). Furthermore, significant Current Good Manufacturing Practice (CGMP) violations, leading to adulteration under FDCA section 501(a)(2)(B), included failures to establish adequate air supply (21 CFR 211.42(c)(10)(iii)), appropriate written procedures for contamination prevention and validation (21 CFR 211.113(b)), ensure proper personnel clothing (21 CFR 211.28(a)), establish environmental monitoring (21 CFR 211.42(c)(10)(iv)), and conduct laboratory determination of conformance to specifications for sterile products (21 CFR 211.167(a)). The California State Board of Pharmacy issued embargoes, a cease and desist order, and cancelled the firm's sterile compounding license, which the firm voluntarily relinquished, stating it would cease sterile compounding. FDA recommends a comprehensive assessment and full CGMP implementation if sterile operations are resumed, requiring a written response within fifteen working days.