FDA 483 - Playtex Manufacturing, Inc. - Plant #2 - April 07, 2025

Playtex Manufacturing, Inc. in Sidney, OH, was cited for significant deficiencies in their manufacturing and quality control processes for OTC drug products, particularly Benzalkonium 0.13% Anti-Bacterial Hand wipes. The inspection revealed inadequate laboratory controls, unwritten quality unit procedures, insufficient investigations into product contamination and OOS results, and poor equipment cleaning validation. Additionally, the firm failed to qualify its water system and exhibited data integrity concerns with HPLC software access.