FDA Inspection
Bristol-Myers Squibb Holdings Pharma Ltd. Liability CompanyBristol-Myers Squibb Holdings Pharma Ltd. Liability Company – FDA Inspection, Mar 31, 2010
Record Details
This FDA Inspection record concerns Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company, with an inspection on March 31, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 31, 2010
- Product Type
- Drugs
View Company Profile
ID · 35af1e20-3d32-447c-af22-641b0d3f43c3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 654640
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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| February 13, 2026 | Not classified | San Juan District Office | |
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| 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 |
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