FDA Inspection 751008 — Raining Rose, Inc.
The FDA completed an inspection of Raining Rose, Inc. on October 25, 2011 in Cedar Rapids, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cedar Rapids, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |