FDA Inspection 1101320 — G.S. Cosmeceutical USA, Inc.
The FDA completed an inspection of G.S. Cosmeceutical USA, Inc. on August 14, 2019 in Livermore, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Livermore, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |