FDA Inspection 1158526 — Genlabs Corporation
The FDA completed an inspection of Genlabs Corporation on December 9, 2021 in Chino, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 9, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1218 | 21 CFR 211.67(b)(1) | Cleaning SOP/responsibility |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |