FDA Inspection
B. Braun Medical IncB. Braun Medical Inc – FDA Inspection, Mar 3, 2015
Record Details
This FDA Inspection record concerns B. Braun Medical Inc, with an inspection on March 3, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B. Braun Medical Inc
- Inspection Date
- March 3, 2015
- Product Type
- Drugs
View Company Profile
ID · 3a21655c-aec3-4d43-9d43-94c20e048f7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917536
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of B. Braun Medical Inc
14| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| 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 |
Other documents for B. Braun Medical Inc
- FDA Inspection 1292536 - 2025-11-21
- FDA Inspection 1231010 - 2024-08-06
- FDA Inspection 1226163 - 2023-12-15
- FDA Inspection 1222593 - 2023-10-13
- FDA Inspection 1152417 - 2021-08-17
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