# FDA 483 - St Mary's Medical Park Pharmacy - December 04, 2025

Source: https://www.keypedia.com/records/483/st-marys-medical-park-pharmacy/e7a06212-30c8-499a-80af-ce2131223006

> FDA 483 for St Mary's Medical Park Pharmacy on December 04, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: St Mary's Medical Park Pharmacy
- Inspection Date: 2025-12-04
- Product Type: drugs
- Office Name: Denver District Office
- Summary: St Mary's Medical Park Pharmacy, a relabeler and repackager in Oro Valley, AZ, was cited for significant deficiencies across its quality system. The inspection revealed a lack of an independent Quality Unit, inadequate investigation procedures for complaints and deviations, unvalidated production processes, and insufficient environmental monitoring. Furthermore, the firm demonstrated poor control over computer systems, deficient batch records, unrepresentative reserve samples, and inadequate equipment calibration protocols.

## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/st-marys-medical-park-pharmacy/fb51249b-b340-447c-9be2-0bc6b7c391e8

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face