# FDA 483 - Predictable Surgical Technologies - November 18, 2021

Source: https://www.keypedia.com/records/483/predictable-surgical-technologies/8ed5c03e-5266-4684-bc6d-e7bd8628222e

> FDA 483 for Predictable Surgical Technologies on November 18, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Predictable Surgical Technologies
- Inspection Date: 2021-11-18
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Predictable Surgical Technologies in Hebron, KY, a human tissue distributor, revealed significant deficiencies in their quality systems and procedures for handling Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to establish appropriate standard operating procedures for storage, receipt, and distribution of HCT/Ps, lacked a method for tracking distinct identification codes for distributed HCT/Ps, and did not have a comprehensive quality program addressing core CGTP requirements.

## Related Documents

- [483 - 2023-11-08](https://www.keypedia.com/records/483/predictable-surgical-technologies/c63e106f-0552-48d4-9d2d-c14d8207dcd2)

## Related Officers

- [Jennifer L. Sheehan](https://www.keypedia.com/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.keypedia.com/companies/predictable-surgical-technologies/83319a12-1085-4f42-93f9-1d2e551925aa

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22