FDA Inspection 747091 — Sunrise Pharmaceutical, Inc.
The FDA completed an inspection of Sunrise Pharmaceutical, Inc. on October 4, 2011 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
- October 4, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rahway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |