FDA Inspection
Azurity Pharmaceuticals, Inc.Azurity Pharmaceuticals, Inc. – FDA Inspection, Feb 24, 2022
Record Details
This FDA Inspection record concerns Azurity Pharmaceuticals, Inc., with an inspection on February 24, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 24, 2022
- Product Type
- Drugs
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ID · 12a62341-3a2c-4ccd-af8a-ac1ef6bbb9ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1163010
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
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Other FDA inspections of Azurity Pharmaceuticals, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2025 | NAI | Drug Quality Assurance | |
| February 19, 2025 | Not classified | New England District Office | Drug Quality Assurance |
| March 2, 2023 | Not classified | New England District Office | Drug Quality Assurance |
| July 26, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2017 | Not classified | New England District Office |
Other documents for Azurity Pharmaceuticals, Inc.
- FDA Inspection 1297348 - 2025-12-12
- FDA Inspection 1261303 - 2025-02-19
- FDA Inspection 1199279 - 2023-03-02
- FDA Inspection 1100022 - 2019-07-26
- FDA Inspection 1038444 - 2017-12-20
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