FDA Inspection 1037112 — Raritan Pharmaceuticals, Inc.
The FDA completed an inspection of Raritan Pharmaceuticals, Inc. on Jan 8, 2018 in East Brunswick, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 8, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4576 | 21 CFR 211.192 | No written record of investigation |