FDA Inspection
Bristol-Myers Squibb Holdings Pharma Ltd. Liability CompanyBristol-Myers Squibb Holdings Pharma Ltd. Liability Company – FDA Inspection, Jul 12, 2021
Record Details
This FDA Inspection record concerns Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company, with an inspection on July 12, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 12, 2021
- Product Type
- Drugs
View Company Profile
ID · 9fcd9e71-f132-4105-8b68-5dc2df75c023
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147009
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
13| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | San Juan District Office | |
| June 6, 2024 | Not classified | San Juan District Office | |
| November 19, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 11, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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