FDA Inspection 1137445 — Weckerle Cosmetics USA, INC
The FDA completed an inspection of Weckerle Cosmetics USA, INC on March 26, 2021 in Torrance, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4576 | 21 CFR 211.192 | No written record of investigation |