# FDA 483 - Medwest Associates - August 27, 2025

Source: https://www.globalkeysolutions.net/records/483/medwest-associates/791daad9-6fcc-46e1-bbd2-f33b3fe8e515

> 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: Chicago District Office
- Summary: Lightbody Medical Technologies Inc dba Artemis Surgical, an HCT/P distributor in Burr Ridge, IL, was cited for failing to properly evaluate incoming human cells, tissues, and cellular and tissue-based products (HCT/Ps) for microorganisms, damage, and contamination. The firm also failed to document verification activities for product acceptance, rejection, or quarantine, and did not review or document that release criteria were met before distributing HCT/Ps. These failures indicate significant deficiencies in quality control and record-keeping for distributed HCT/Ps.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669