FDA Inspection
Avista Pharma Solutions, Inc.Avista Pharma Solutions, Inc. – FDA Inspection, Sep 27, 2013
Record Details
This FDA Inspection record concerns Avista Pharma Solutions, Inc., with an inspection on September 27, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 27, 2013
- Product Type
- Drugs
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ID · 51fdbe29-4c8a-4db0-b664-5ef7edf67340
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850250
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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 |
| July 25, 2025 | VAI | New England District Office | Drug Quality Assurance |
| 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 |
Other documents for Avista Pharma Solutions, Inc.
- FDA Inspection 1332618 - 2026-08-14
- FDA Inspection 1278383 - 2025-07-25
- FDA Inspection 1113974 - 2019-12-18
- FDA Inspection 1067530 - 2018-09-05
- FDA Inspection 988732 - 2016-06-15
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