FDA Inspection 1116454 — Raining Rose, Inc.
The FDA completed an inspection of Raining Rose, Inc. on January 24, 2020 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
- January 24, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cedar Rapids, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |