# B. Braun US Pharmaceutical Manufacturing LLC – FDA 483, Nov 22, 2022

Source: https://www.keypedia.com/records/483/b-braun-us-pharmaceutical-manufacturing-llc/1fd1fc7b-4985-4e05-9cf7-94317763ef8f

> FDA 483 for B. Braun US Pharmaceutical Manufacturing LLC on November 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun US Pharmaceutical Manufacturing LLC
- Inspection Date: 2022-11-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of B. Braun Medical Inc. in Daytona Beach, FL, a sterile drug manufacturer, revealed significant deficiencies across quality control, production, and laboratory operations. The firm failed to adequately investigate product discrepancies, distributed unreleased products, and exhibited poor adherence to established procedures for visual inspections, sterility testing, and laboratory data integrity. These issues indicate a lack of robust quality oversight and could impact the quality and safety of their sterile drug products.

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## Related Officers

- [Michelle K Cockrill](https://www.keypedia.com/people/michelle-k-cockrill/8bf9ed2e-03fc-41ea-a33a-31a31cfdbc7e)
- [Microbiologist](https://www.keypedia.com/people/michael-t-cyrus/30e497e1-2c17-4dd7-9a5b-251771cf4266)
- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

Company: https://www.keypedia.com/companies/b-braun-us-pharmaceutical-manufacturing-llc/9ed3959a-40a0-45d0-ba4b-e4dab3b3f3e4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6