FDA Inspection 890300 — ROIS Phoenix Inc
The FDA completed an inspection of ROIS Phoenix Inc on August 8, 2014 in Phoenix, AZ. 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
- August 8, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |