Abrams Royal Pharmacy – FDA Warning Letter, Dec 20, 2013

The FDA issued a Warning Letter to Abrams Royal Pharmacy, Inc. following an inspection from December 12-20, 2013, which revealed significant violations. The firm was found to be producing drug products without valid prescriptions for individually-identified patients, rendering these drugs unapproved new drugs and misbranded under FDCA sections 505(a) and 502(f)(1).

Furthermore, serious deficiencies in sterile drug product manufacturing practices were observed, leading to adulteration charges under FDCA section 501(a)(2)(A) and (B). Violations included operators wearing non-sterile gowns/gloves with exposed skin, poor aseptic technique (e.g., picking items from the floor), failure to use sporicidal cleaning agents, and inadequate demonstration of hood protection for ISO 5 areas. The firm also failed to establish appropriate written procedures for preventing microbiological contamination (21 CFR 211.113(b)), adequately design facilities to prevent contamination (21 CFR 211.42(b)), ensure appropriate personnel clothing (21 CFR 211.28(a)), establish adequate cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)), monitor environmental conditions (21 CFR 211.42(c)(10)(iv)), and establish a stability testing program (21 CFR