FDA Inspection 1030617 — Playtex Manufacturing Inc
The FDA completed an inspection of Playtex Manufacturing Inc on Nov 3, 2017 in Ormond Beach, FL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 3, 2017
- Fiscal Year
- 2018
- 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 |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |