FDA Inspection 1059468 — Genus Lifesciences Inc.
The FDA completed an inspection of Genus Lifesciences Inc. on July 20, 2018 in Allentown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |