FDA Inspection
Laboratoires Besins InternationalLaboratoires Besins International – FDA Inspection, Mar 12, 2015
Record Details
This FDA Inspection record concerns Laboratoires Besins International, with an inspection on March 12, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 12, 2015
- Product Type
- Drugs
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ID · d8329736-af4f-4a11-946b-8f1c6b1c97e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 922059
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Laboratoires Besins International
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratoires Besins International
- FDA Inspection 1268507 - 2022-04-20
- FDA Inspection 1124020 - 2019-03-13
- FDA Inspection 829654 - 2013-03-08
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