FDA Inspection
Saptalis Pharmaceuticals LLCSaptalis Pharmaceuticals LLC – FDA Inspection, Mar 6, 2026
Record Details
This FDA Inspection record concerns Saptalis Pharmaceuticals LLC, with an inspection on March 6, 2026, issued by the New York District Office, covering human drugs.
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ID · 110d88c7-f70f-498e-9269-9b842cc13af6
Inspection Facts
- Inspection number
- 1305912
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Saptalis Pharmaceuticals LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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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