# FDA 483 - Playtex Manufacturing Inc - April 19, 2023

Source: https://www.keypedia.com/records/483/playtex-manufacturing-inc/435079dd-363b-4286-a650-5044abbe2682

> FDA 483 for Playtex Manufacturing Inc on April 19, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Playtex Manufacturing Inc
- Inspection Date: 2023-04-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/playtex-manufacturing-inc/8b296cac-4ea3-4cd1-8981-a463c6f66e2b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6