FDA Inspection
Bristol-Myers Squibb Manufacturing Company Unlimited CompanyBristol-Myers Squibb Manufacturing Company Unlimited Company – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns Bristol-Myers Squibb Manufacturing Company Unlimited Company, with an inspection on November 18, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 18, 2016
- Product Type
- Drugs
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ID · 370f4219-d7b2-489a-8328-b3cd7127553f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993014
- 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 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| April 27, 2018 | 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 1051117 - 2018-04-27
- FDA Inspection 956226 - 2015-12-09
- FDA Inspection 866747 - 2014-02-20
- FDA Inspection 768189 - 2012-02-02
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