EMS Acquisition Corp – FDA 483, Jul 22, 2022

EMS Contract Packaging, a pharmaceutical manufacturer in Hatfield, PA, was inspected by the FDA from July 18-22, 2022. The inspection revealed a repeat observation from 2015 concerning the absence of written procedures for production and process controls. Specifically, the firm failed to validate or verify manufacturing and filling processes for its OTC drug products, indicating a significant deficiency in ensuring product quality and purity.