# B. Braun US Pharmaceutical Manufacturing LLC – FDA 483, Nov 5, 2021

Source: https://www.keypedia.com/records/483/b-braun-us-pharmaceutical-manufacturing-llc/2acd4053-df37-42e3-b3b4-59fc224d6a80

> FDA 483 for B. Braun US Pharmaceutical Manufacturing LLC on November 05, 2021. 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: 2021-11-05
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: B. Braun Medical Inc., a sterile drug manufacturer in Daytona Beach, FL, received a Form 483 with four observations. The inspection revealed significant issues including inadequate CAPA procedures, failure to control microbial contamination in the Water for Injection system, unvalidated reprocessing steps for IV bags, and non-adherence to visual inspection procedures and qualification requirements. These findings indicate a moderate level of severity regarding quality system deficiencies and potential product integrity risks.

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## Related Officers

- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)
- [Nakesha J Jackson](https://www.keypedia.com/people/nakesha-j-jackson/7ff47efe-9786-4296-b8c3-6fb5a25b805e)
- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

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