FDA WARNING_LETTER - FVS Holdings, Inc. dba. Green Valley Drugs - March 15, 2013

The FDA issued a Warning Letter to FVS Holdings, Inc. dba. Green Valley Drugs following a March 2013 inspection, revealing significant violations. The firm failed to receive valid prescriptions for individually-identified patients for many drug products. Serious deficiencies in sterile drug production were observed, including non-sterile glove contact with sterile components, staff reaching over uncapped vials, and uncovered sterile vial storage, leading to insanitary conditions and potential microbial contamination. The firm voluntarily recalled all sterile products and committed to ceasing sterile production. The manufactured drug products are deemed unapproved new drugs (FDCA 505(a), 301(d)) lacking FDA-approved applications, and misbranded (FDCA 502(f)(1), 301(a)) due to inadequate directions for use. Sterile products are adulterated (FDCA 501(a)(2)(A)) due to insanitary conditions and (FDCA 501(a)(2)(B)) for numerous Current Good Manufacturing Practice (CGMP) violations. These CGMP failures include inadequate written procedures for contamination prevention (21 CFR 211.113(b)), poor facility design (21 CFR 211.42(b)), lack of stability testing (21 CFR 211.166(a)), insufficient cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)), inappropriate personnel clothing (21 CFR 211.28(a)), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), and absence of final specification conformance determination for sterile batches (21 CFR 211.167(a)). Green Valley Drugs must promptly correct all violations and notify the FDA within fifteen working days with a detailed plan and supporting documentation. The FDA strongly recommends a comprehensive assessment of manufacturing operations, potentially with a third-party consultant. Non-compliance may lead to legal action, including seizure and injunction.