FDA Inspection 674159 — Kenvue Brands LLC
The FDA completed an inspection of Kenvue Brands LLC on June 16, 2010 in Lititz, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lititz, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1207 | 21 CFR 211.65(b) | Substances That Come in Contact |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |