FDA Inspection
B. Braun US Pharmaceutical Manufacturing LLCB. Braun US Pharmaceutical Manufacturing LLC – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns B. Braun US Pharmaceutical Manufacturing LLC, with an inspection on September 25, 2026, issued by the Florida District Office, covering human drugs.
- Inspection Date
- September 25, 2026
- Product Type
- Human Drugs
- Office
- Florida District Office
- People
- Cecilia H. Kieu (FDA Associated Person)
- David L. Cech (Issuing Officer)
- Homero W. Aguilar
- Ivis L. Negron Torres (Issuing Officer)
- Joey V. Quitania (FDA Associated Person)
- Kamyl Y. Guzman Morales (Issuing Officer)
- Margaret M. Annes (FDA Associated Person)
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ID · a0f1b5b4-a05f-4614-beb2-5a170d60afb0
Inspection Facts
- Inspection number
- 1334920
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 211.110(b)In-process conformity - examination, sample testing
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.204Returned drug procedures in writing and followed
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Other FDA inspections of B. Braun US Pharmaceutical Manufacturing LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| November 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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