# FDA 483 - B. Braun Medical, Inc. - August 26, 2016

Source: https://www.keypedia.com/records/483/b-braun-medical-inc/bddf44af-a6ec-48a1-96d8-1be6531a33fe

> FDA 483 for B. Braun Medical, Inc. on August 26, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun Medical, Inc.
- Inspection Date: 2016-08-26
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: B. Braun Medical, Inc. in Allentown, PA, a medical device manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to submit multiple Medical Device Reports (MDRs) within 30 days for device malfunctions that could cause serious injury or death. Additionally, the company did not adequately document corrective and preventive action (CAPA) activities and results, including issues with recurring problems.

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## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)
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Company: https://www.keypedia.com/companies/b-braun-medical-inc/904b6715-c8e7-4548-89d4-7a738d228858

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8