FDA Inspection
Bristol-Myers Squibb Manufacturing Company Unlimited CompanyBristol-Myers Squibb Manufacturing Company Unlimited Company – FDA Inspection, Apr 27, 2018
Record Details
This FDA Inspection record concerns Bristol-Myers Squibb Manufacturing Company Unlimited Company, with an inspection on April 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 27, 2018
- Product Type
- Drugs
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ID · 105141ec-8990-4937-bc2f-e314d1fa1be6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051117
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Bristol-Myers Squibb Manufacturing Company Unlimited Company
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bristol-Myers Squibb Manufacturing Company Unlimited Company
- FDA Inspection 1121802 - 2020-02-14
- FDA Inspection 993014 - 2016-11-18
- FDA Inspection 956226 - 2015-12-09
- FDA Inspection 866747 - 2014-02-20
- FDA Inspection 768189 - 2012-02-02
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