FDA Inspection
Baccinex SaBaccinex Sa – FDA Inspection, Oct 28, 2022
Record Details
This FDA Inspection record concerns Baccinex Sa, with an inspection on October 28, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Baccinex Sa
- Inspection Date
- October 28, 2022
- Product Type
- Drugs
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ID · ca593102-a960-4cac-be2b-45486fcad1cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1193141
- 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 211.63Equipment Design, Size and Location
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Baccinex Sa
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2019 | OAI | Office of Inspections and Investigations | New Drug Evaluation |
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