1294642
St Mary's Medical Park Pharmacy — FEI 1000160560
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oro Valley, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |