Village Fertility Pharmacy, Inc. – FDA 483, Mar 13, 2013

An FDA inspection of Village Fertility Pharmacy, Inc., conducted from February 21 to March 13, 2013, revealed critical deficiencies in the production of sterile drug products. Inspectors observed visible particulates in multiple lots of sterile injectable Progesterone in Ethyl Oleate and Progesterone in Sesame Oil. The company failed to adequately evaluate product integrity incident reports from patients and healthcare practitioners regarding these particulates, neglecting to perform root-cause analyses or implement corrective and preventive actions to avoid future occurrences.

Further observations indicated a lack of validated sterilization processes. The firm provided no documentation to support the effectiveness of sterilization cycles used for glass vials, stoppers, or for drug formulations compounded from non-sterile active pharmaceutical ingredients and raw materials. A significant concern involved Leuprolide 40mcg/0.1ml, Lot K2312-20, where initial potency testing showed a result of 196.8% of the expected dose, while a second test yielded 97.8%. Despite these conflicting results, no investigation was performed, and eight vials from this lot were dispensed to patients.

These findings, detailed in an FDA Form 483, signify practices that could impact product quality and patient safety. Village Fertility Pharmacy is expected to respond to these observations by outlining corrective actions and preventive measures.