# FDA 483 - B. Braun Medical Inc. - October 30, 2020

Source: https://www.globalkeysolutions.net/records/483/b-braun-medical-inc/b3f9399a-9c41-4167-a346-de82bf050c5c

> FDA 483 for B. Braun Medical Inc. on October 30, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun Medical Inc.
- Inspection Date: 2020-10-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: B. Braun Medical Inc. in Daytona Beach, FL, a sterile drug manufacturer, received a Form 483 with nine observations during an inspection from October 19-30, 2020. The observations highlight significant deficiencies across its quality control, production, computer systems, environmental controls, material testing, and laboratory practices. Key issues include inadequate process validation, poor data integrity controls, and a failure to follow established SOPs for manufacturing and quality oversight.

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Company: https://www.globalkeysolutions.net/companies/b-braun-medical-inc/9ed3959a-40a0-45d0-ba4b-e4dab3b3f3e4

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