FDA 483 - Wedgewood Village Pharmacy, LLC - March 24, 2022

An FDA inspection of Wedgewood Village Pharmacy, LLC in Swedesboro, NJ, a producer of sterile and non-sterile drug products, revealed multiple critical deficiencies. Observations included widespread non-microbial and microbial contamination in production areas, inadequate aseptic processing practices, failed HEPA filters, and vermin infestations in storage areas. These findings indicate a severe lack of control over environmental conditions and manufacturing processes, posing significant risks to drug product quality and patient safety.