# FDA 483 - Berkeley Advanced Biomaterials, LLC - November 22, 2024

Source: https://www.keypedia.com/records/483/berkeley-advanced-biomaterials-llc/7b268965-c8b4-4785-a1ea-7a43be0a2191

> FDA 483 for Berkeley Advanced Biomaterials, LLC on November 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkeley Advanced Biomaterials, LLC
- Inspection Date: 2024-11-22
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Berkeley Advanced Biomaterials, LLC, a tissue processor in Berkeley, CA, received an FDA Form 483 with three observations during an inspection from November 15-22, 2024. The firm was cited for failing to prevent contamination and cross-contamination during HCT/P processing, lacking environmental monitoring for bone processing, and maintaining inadequate records for cleaning, equipment use, and product compounding. These issues indicate significant deficiencies in the firm's quality control and record-keeping practices.

## Related Documents

- [483 - 2024-11-22](https://www.keypedia.com/records/483/berkeley-advanced-biomaterials-llc/040da3ea-0bf4-4895-9281-93fdbe500caa)

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.keypedia.com/companies/berkeley-advanced-biomaterials-llc/39f72730-d455-4d24-8dfd-43750ed40672

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b