FDA Inspection
Saptalis Pharmaceuticals LLCSaptalis Pharmaceuticals LLC – FDA Inspection, Mar 17, 2023
Record Details
This FDA Inspection record concerns Saptalis Pharmaceuticals LLC, with an inspection on March 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 743fd85a-c506-4838-8be4-90c8775b5a06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200278
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.89Quarantine of Rejected Components et. al.
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Other FDA inspections of Saptalis Pharmaceuticals LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| September 9, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 30, 2018 | Not classified | New York District Office | |
| March 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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