FDA Inspection
Avista Pharma Solutions, Inc.Avista Pharma Solutions, Inc. – FDA Inspection, Jul 25, 2025
Record Details
This FDA Inspection record concerns Avista Pharma Solutions, Inc., with an inspection on July 25, 2025, issued by the New England District Office, covering human drugs.
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ID · 07d264c9-9218-4fc2-92ce-25f1f2348432
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1278383
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Avista Pharma Solutions, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2026 | Not classified | New England District Office | Human Cellular, Tissue, and Gene Therapies |
| December 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 5, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Avista Pharma Solutions, Inc.
- FDA Inspection 1332618 - 2026-08-14
- FDA Inspection 1113974 - 2019-12-18
- FDA Inspection 1067530 - 2018-09-05
- FDA Inspection 988732 - 2016-06-15
- FDA Inspection 850250 - 2013-09-27
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