FDA 483 - Playtex Manufacturing Inc. - May 03, 2019

Playtex Manufacturing Inc. in Dover, DE, was inspected by the FDA from April 29 to May 3, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically the failure to conduct scheduled quality audits. Additionally, the firm failed to submit multiple Medical Device Report (MDR) reports within the required 30-day timeframe.