Playtex Manufacturing IncApril 19, 2023

FDA 483 - Playtex Manufacturing Inc - April 19, 2023

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Playtex Manufacturing Inc

Record Details

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.

Company: Playtex Manufacturing Inc
Inspection Date: April 19, 2023
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Brittny C. Cargo (Medical Officer at FDA)

Open in Dashboard

ID · 435079dd-363b-4286-a650-5044abbe2682