FDA Inspection 702529 — Sunrise Pharmaceutical, Inc.
The FDA completed an inspection of Sunrise Pharmaceutical, Inc. on December 20, 2010 in Rahway, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rahway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |