FDA Inspection
Ascent Pharmaceuticals IncAscent Pharmaceuticals Inc – FDA Inspection, Aug 9, 2024
Record Details
This FDA Inspection record concerns Ascent Pharmaceuticals Inc, with an inspection on August 9, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ad54fbcb-6020-4316-b662-c5582cc31d0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229681
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Ascent Pharmaceuticals Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2025 | Not classified | New York District Office | |
| September 15, 2022 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 13, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 27, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ascent Pharmaceuticals Inc
- FDA Inspection 1261247 - 2025-02-03
- FDA Inspection 1179615 - 2022-09-15
- FDA Inspection 1132410 - 2020-10-13
- FDA Inspection 1074882 - 2018-11-07
- FDA Inspection 1067030 - 2018-07-27
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