FDA Inspection
Baccinex SaBaccinex Sa – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Baccinex Sa, with an inspection on July 26, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · c1c48319-6de7-4e56-bb53-b8f8c797be6c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1097584
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.184(e)Records of disposition of rejected material
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
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Other FDA inspections of Baccinex Sa
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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