FDA Inspection
B. Braun Medical IncB. Braun Medical Inc – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns B. Braun Medical Inc, with an inspection on November 21, 2025, issued by the Los Angeles District Office, covering human drugs.
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ID · 4b5bf5cb-b77d-4940-9a4e-a9b0e76cf953
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1292536
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued, view the record
FDA Citations
6- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of B. Braun Medical Inc
14| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 13, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for B. Braun Medical Inc
- FDA Inspection 1231010 - 2024-08-06
- FDA Inspection 1226163 - 2023-12-15
- FDA Inspection 1222593 - 2023-10-13
- FDA Inspection 1152417 - 2021-08-17
- FDA Inspection 1057639 - 2018-06-29
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