FDA Inspection 995165 — Raritan Pharmaceuticals, Inc.
The FDA completed an inspection of Raritan Pharmaceuticals, Inc. on Oct 20, 2016 in East Brunswick, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 20, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3641 | 21 CFR 211.204 | Record information inclusions |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |