FDA Inspection 1088636 — Playtex Manufacturing Inc.
The FDA completed an inspection of Playtex Manufacturing Inc. on May 3, 2019 in Dover, DE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 3, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dover, DE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |