# FDA 483 - OsteoLife Biomedical, LLC - January 27, 2022

Source: https://www.globalkeysolutions.net/records/483/osteolife-biomedical-llc/62a6bbe8-936d-49dd-bded-e5339d3e78d4

> FDA 483 for OsteoLife Biomedical, LLC on January 27, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OsteoLife Biomedical, LLC
- Inspection Date: 2022-01-27
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of OsteoLife Biomedical, LLC in Jupiter, FL, an HCT/P storage and distribution facility, revealed significant deficiencies. The firm failed to establish and implement a tracking system for HCT/Ps from donor to consignee. Additionally, the company lacked appropriate procedures for core CGTP requirements, including environmental control, product recall, and product receipt, storage, and distribution.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.globalkeysolutions.net/companies/osteolife-biomedical-llc/c261577a-182d-46e1-a083-3386d3216ec8

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6