FDA Inspection
St Mary's Medical Park PharmacySt Mary's Medical Park Pharmacy – FDA Inspection, Dec 4, 2025
Record Details
This FDA Inspection record concerns St Mary's Medical Park Pharmacy, with an inspection on December 4, 2025, issued by the Denver District Office, covering human drugs.
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ID · 1870e85e-66b5-4f6b-84a3-85fe04522e3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1294642
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of St Mary's Medical Park Pharmacy
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 19, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for St Mary's Medical Park Pharmacy
- FDA Inspection 1145695 - 2021-06-11
- FDA Inspection 983912 - 2016-07-27
- FDA Inspection 726905 - 2011-05-19
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