FDA Inspection 1171967 — Jerome Stevens Pharmaceuticals, Inc.
The FDA completed an inspection of Jerome Stevens Pharmaceuticals, Inc. on June 15, 2022 in Bohemia, NY. 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 15, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bohemia, NY (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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |