# FDA 483 - SGF Tampa Bay LLC - February 24, 2020

Source: https://www.keypedia.com/records/483/sgf-tampa-bay-llc/ecaf4e61-3f29-440a-8e80-f0bf4e539e11

> FDA 483 for SGF Tampa Bay LLC on February 24, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SGF Tampa Bay LLC
- Inspection Date: 2020-02-24
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: SGF Tampa Bay LLC, a reproductive tissue establishment, was cited for multiple deficiencies related to donor screening, record-keeping, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed failures in screening donors for communicable disease risks, incomplete records for ineligible donors, and improper labeling of HCT/Ps with biohazard warnings. Additionally, the firm failed to ensure its contract laboratory complied with good tissue practice requirements and maintained legible donor eligibility records.

## Related Officers

- [investigator](https://www.keypedia.com/people/samantha-j-pinizzotto/296e8763-39e9-4b6d-9b89-661322d5a53c)

Company: https://www.keypedia.com/companies/sgf-tampa-bay-llc/758753c2-daed-487f-b9d1-74594329edfd

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