FDA 483 - Playtex Manufacturing Inc - April 19, 2023

Playtex Manufacturing Inc, an OTC drug manufacturer in Ormond Beach, FL, received a Form 483 with four observations. The inspection revealed significant issues with data integrity in their electronic batch record system, inadequate quality unit oversight, and failures in OOS investigations. Additionally, the firm did not follow its own procedures for supplier re-qualification, which was noted as a repeat observation.