FDA Inspection
Exeltis USA, Inc.Exeltis USA, Inc. – FDA Inspection, Jun 6, 2017
Record Details
This FDA Inspection record concerns Exeltis USA, Inc., with an inspection on June 6, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9ab7c541-da1d-41e2-8960-4fde32f2506c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014140
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.320(a)Examination, testing; appropriate
- 21 CFR 111.123(a)(7)Quality control operations - finished batch, specifications
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Other FDA inspections of Exeltis USA, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2026 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 2, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 15, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 14, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Exeltis USA, Inc.
- FDA Inspection 1333134 - 2026-09-22
- FDA Inspection 1250586 - 2025-07-02
- FDA Inspection 1232731 - 2024-11-15
- FDA Inspection 1076534 - 2019-01-14
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