FDA 483 - Village Pharmacy - June 22, 2016

An FDA inspection of Village Pharmacy, a producer of non-sterile drug products located at 1280 Yardville-Allentown Rd, Allentown, NJ, was conducted from June 14-22, 2016. The inspection, led by Investigators Paul L. Bellamy and Nancy M. Espinal, resulted in a Form 483 being issued to Ms. Ann Ervin, Pharmacist in Charge.

The primary observation noted was the absence of a written testing program to assess the stability characteristics of drug products. Specifically, there was no analytical data to support the label claim potency of multiple products at the time of dispensing or throughout their labeled six-month beyond-use dates. These dispensed products were for medical office use, not patient-specific.

Examples cited include: * Hydroxyzine Pamoate 25mg/5ml Suspension (human use) * Gabapentin 50mg/ml Fixed Oil Suspension (animal use) * Ondansetron 4mg/ml Suspension (animal use) * Piroxicam 5mg Capsules (animal use), for which the prescription label listed a one-year beyond-use date (10/12/2016) despite preparation instructions indicating a six-month beyond-use date, with no explanation for the discrepancy.

This observation indicates a deficiency in quality control regarding product stability and potency assurance, potentially impacting