FDA Inspection
Ascent Pharmaceuticals IncAscent Pharmaceuticals Inc – FDA Inspection, Sep 15, 2022
Record Details
This FDA Inspection record concerns Ascent Pharmaceuticals Inc, with an inspection on September 15, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ascent Pharmaceuticals Inc
- Inspection Date
- September 15, 2022
- Product Type
- Drugs
View Company Profile
ID · 23ea7cb5-85bb-4ee6-96ce-1106d4aec03b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1179615
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- Failure to comply with REMS Implementation System
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ascent Pharmaceuticals Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2025 | Not classified | New York District Office | |
| August 9, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1229681 - 2024-08-09
- FDA Inspection 1132410 - 2020-10-13
- FDA Inspection 1074882 - 2018-11-07
- FDA Inspection 1067030 - 2018-07-27
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