FDA Inspection
Azurity Pharmaceuticals, Inc.Azurity Pharmaceuticals, Inc. – FDA Inspection, Mar 2, 2023
Record Details
This FDA Inspection record concerns Azurity Pharmaceuticals, Inc., with an inspection on March 2, 2023, issued by the New England District Office.
- Inspection Date
- March 2, 2023
- Person
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ID · d81f0586-7c5d-4396-a80e-766283dec67c
Inspection Facts
- Inspection number
- 1199279
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192No written record of investigation
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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 |
| February 24, 2022 | VAI | Center for Drug Evaluation and Research | 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 1163010 - 2022-02-24
- FDA Inspection 1100022 - 2019-07-26
- FDA Inspection 1038444 - 2017-12-20
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