FDA WARNING_LETTER - Pine Pharmacy and Home Care Products Center, Inc. - December 16, 2013

The FDA issued a Warning Letter to Pine Pharmacy and Home Care Products Center, Inc. following inspections in July and December 2013, the latter conducted under an administrative warrant due to initial non-cooperation. Significant violations included producing drugs without valid prescriptions for individually-identified patients and serious deficiencies in sterile drug production. These deficiencies involved operators with exposed skin and non-sterile gowns, and failure to demonstrate adequate ISO 5 area protection. The firm compounded domperidone and Brilliant Blue G, substances not permitted under FDCA section 503A, as they lack USP/NF monographs, are not FDA-approved drug components, nor on a Secretary's list. These products are consequently unapproved new drugs (FDCA 505(a)) and misbranded (FDCA 502(f)(1)). Sterile drug products were prepared under insanitary conditions, rendering them adulterated (FDCA 501(a)(2)(A)). Further, the firm incurred significant Current Good Manufacturing Practice (CGMP) violations (21 CFR 210 and 211), leading to adulterated drugs (FDCA 501(a)(2)(B)). These included failures in written procedures for sterile product contamination prevention and validation (211.113(b)), appropriate personnel clothing (211.28(a)), environmental monitoring (211.42(c)(10)(iv)), cleaning/disinfection (211.42(c)(10)(v)), and stability testing (211.166(a)). FDA recommends a comprehensive operational assessment, potentially with a third-party consultant, to ensure 21 CFR 210 and 211 compliance. Failure to promptly correct these violations may result in legal action. A written response detailing corrective actions is required within fifteen working days.