FDA Inspection
Bristol-Myers Squibb CompanyBristol-Myers Squibb Company – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns Bristol-Myers Squibb Company, with an inspection on August 27, 2026, issued by the New England District Office, covering biologics.
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ID · 4d738ca2-e486-4320-95cb-6dde6f4ee6da
Inspection Facts
- Inspection number
- 1338128
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 600.80(c)Reporting Requirements
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Other FDA inspections of Bristol-Myers Squibb Company
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2025 | Not classified | New England District Office | |
| May 5, 2023 | Not classified | New England District Office | |
| January 10, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2016 | Not classified | New England District Office |
Other documents for Bristol-Myers Squibb Company
- FDA Inspection 1272436 - 2025-07-08
- FDA Inspection 1206159 - 2023-05-05
- FDA Inspection 1115960 - 2020-01-10
- FDA Inspection 1008167 - 2017-04-05
- FDA Inspection 988152 - 2016-10-21
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