FDA Inspection 1203164 — Playtex Manufacturing Inc
The FDA completed an inspection of Playtex Manufacturing Inc on April 19, 2023 in Ormond Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ormond Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |