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

Source: https://www.globalkeysolutions.net/records/483/berkeley-advanced-biomaterials-llc/040da3ea-0bf4-4895-9281-93fdbe500caa

> 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: San Francisco District Office
- Summary: Berkeley Advanced Biomaterials, LLC, a tissue processor in Berkeley, CA, was cited with three observations during an FDA inspection. The firm failed to ensure HCT/Ps were processed without contamination, lacked environmental monitoring for bone processing, and maintained inadequate records for cleaning, equipment, and processing details. These issues indicate significant deficiencies in their quality control and documentation practices.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df