FDA WARNING_LETTER - Village Fertility Pharmacy, Inc. - March 13, 2013

The FDA inspected Village Fertility Pharmacy, Inc. from February 21 to March 13, 2013, uncovering insanitary conditions in the production of injectable drug products like Hydroxyprogesterone Caproate, Progesterone, and Leuprolide Acetate. A Form 483 was issued, and lab analysis confirmed foreign and particulate matter in samples. Violations cited include adulteration under FDCA section 501(a)(2)(A) due to insanitary preparation, specifically using non-sterile equipment, unsuitable sterilization methods, and lacking personnel aseptic monitoring and environmental monitoring. Products were also adulterated under section 501(b) for failing USP particulate matter standards and under section 501(c) for super-potent CPD-Leuprolide Acetate (up to 198.9% of label claim). Additionally, products were misbranded under section 502(a) because injection labeling misleadingly implied freedom from particulates, and the super-potent product was also misbranded. The firm initiated a recall and is under a Massachusetts Board of Pharmacy Cease and Desist order, prohibiting medium/high-risk sterile product production without state approval. FDA recommends a comprehensive third-party assessment of operations to identify root causes. A written response detailing corrective actions and prevention plans is required within fifteen working days, and FDA notification is mandatory before resuming sterile drug production. Failure to comply may result in legal action.