Playtex Manufacturing Inc.May 3, 2019

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

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Record Details

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.

Company: Playtex Manufacturing Inc.
Inspection Date: May 3, 2019
Product Type: Device
Office: Philadelphia District Office
Person: Suzanne M. Healy (Consumer Safety Officer)

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ID · 92b14665-4651-4a79-91a7-38f70e02aba4