# FDA 483 - Medwest Associates - August 27, 2025

Source: https://www.keypedia.com/records/483/medwest-associates/49c29cf3-7bbb-4e9e-8909-44adea80c47f

> FDA 483 for Medwest Associates on August 27, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medwest Associates
- Inspection Date: 2025-08-27
- Product Type: biologics
- Office Name: FDA District Office — Chicago, Illinois
- Summary: An FDA inspection of Lightbody Medical Technologies Inc dba Artemis Surgical, an HCT/P Distributor in Burr Ridge, IL, revealed a significant failure to evaluate incoming Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for microorganisms, damage, and contamination. The firm also failed to document critical activities related to product acceptance, rejection, quarantine, and release criteria before distributing HCT/Ps, which included human amniotic, membrane, bone, cartilage, ligament, skin, tendon, and umbilical cord tissue.

## Related Documents

- [483 - 2025-08-27](https://www.keypedia.com/records/483/medwest-associates/791daad9-6fcc-46e1-bbd2-f33b3fe8e515)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/zoey-a-trombley/cb7ac4dd-bc47-4b51-8fef-a485b122c921)

Company: https://www.keypedia.com/companies/medwest-associates/a5646f1f-116a-4149-bf1f-3ab608a64654

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65