FDA Inspection
Bristol-Myers Squibb CompanyBristol-Myers Squibb Company – FDA Inspection, Sep 3, 2009
Record Details
This FDA Inspection record concerns Bristol-Myers Squibb Company, with an inspection on September 3, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bristol-Myers Squibb Company
- Inspection Date
- September 3, 2009
- Product Type
- Drugs
View Company Profile
ID · 71abe926-609f-49f1-9e56-18a96ea7b7bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611945
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(1)(ii)Failure to separately submit original and follow-up reports
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Bristol-Myers Squibb Company
16| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2026 | Not classified | New Jersey District Office | |
| July 18, 2025 | Not classified | New Jersey District Office | |
| December 6, 2024 | VAI | New Jersey District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| September 6, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 31, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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- FDA Inspection 1247735 - 2024-09-06
- FDA Inspection 1228973 - 2024-01-31
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