FDA Inspection 1118264 — ROIS Phoenix Inc
The FDA completed an inspection of ROIS Phoenix Inc on Feb 19, 2020 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |