FDA Inspection
Sciegen Pharmaceuticals IncSciegen Pharmaceuticals Inc – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Sciegen Pharmaceuticals Inc, with an inspection on May 15, 2026, issued by the New York District Office, covering human drugs.
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ID · a00d1c75-1c9e-4b7c-82cc-eda5065cbf25
Inspection Facts
- Inspection number
- 1317246
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
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Other FDA inspections of Sciegen Pharmaceuticals Inc
13| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2025 | NAI | Bioresearch Monitoring | |
| February 20, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2023 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sciegen Pharmaceuticals Inc
- FDA Inspection 1297968 - 2025-12-19
- FDA Inspection 1229682 - 2024-02-20
- FDA Inspection 1204858 - 2023-04-21
- FDA Inspection 1178870 - 2022-09-02
- FDA Inspection 1159297 - 2021-12-20
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