FDA Inspection 1294642 — St Mary's Medical Park Pharmacy
The FDA completed an inspection of St Mary's Medical Park Pharmacy on December 4, 2025 in Oro Valley, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
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 |