FDA Inspection
Bell International Laboratories, Inc.Bell International Laboratories, Inc. – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns Bell International Laboratories, Inc., with an inspection on June 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 14e71804-8d38-4f3b-bf1a-484a812a65bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016230
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Bell International Laboratories, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | Not classified | Minneapolis District Office | |
| September 19, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 14, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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