FDA Inspection
B. Braun Medical IncB. Braun Medical Inc – FDA Inspection, Feb 13, 2014
Record Details
This FDA Inspection record concerns B. Braun Medical Inc, with an inspection on February 13, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B. Braun Medical Inc
- Inspection Date
- February 13, 2014
- Product Type
- Drugs
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ID · 304c6fb6-71ee-4038-9852-7e62a0aa4e7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866672
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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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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