FDA Inspection
B. Braun Medical IncB. Braun Medical Inc – FDA Inspection, Jun 29, 2018
Record Details
This FDA Inspection record concerns B. Braun Medical Inc, with an inspection on June 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Amanda L. Fyles (Company Rep)
- Carrie A. Hughes (Issuing Officer)
- Evelyn W. Ladines (Issuing Officer)
- Walden H. Lee (FDA Associated Person)
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ID · 59346411-9a05-43f7-8e2d-e6319b8469b0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1057639
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(1)Description and Identification of Samples
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(b)SOPs not followed / documented
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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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