FDA Inspection
B. Braun Medical IncB. Braun Medical Inc – FDA Inspection, May 17, 2013
Record Details
This FDA Inspection record concerns B. Braun Medical Inc, with an inspection on May 17, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B. Braun Medical Inc
- Inspection Date
- May 17, 2013
- Product Type
- Drugs
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ID · 2a2993d9-7639-4660-a6a0-6b0949c5a2db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833727
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.170(b)Investigation of reserve sample deterioration
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.22(c)Approve or reject procedures or specs
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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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