FDA Inspection 865806 — Playtex Manufacturing, Inc.
The FDA completed an inspection of Playtex Manufacturing, Inc. on January 6, 2014 in Sidney, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 6, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sidney, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |