# FDA 483 - SpecGx LLC - February 27, 2026

Source: https://www.globalkeysolutions.net/records/483/specgx-llc/1114cee7-20e5-4785-b5c5-5f8988e4a98c

> FDA 483 for SpecGx LLC on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecGx LLC
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: SpecGx, LLC in Greenville, IL, was inspected from February 24-27, 2026, and received one observation regarding the delegation of quality unit responsibilities for raw material release. The firm was cited for relying on Certificates of Analysis without performing identity testing for a raw material and for using an off-site Quality Assurance unit for release decisions on materials for the Greenville site. These practices indicate potential deficiencies in the firm's quality control over incoming materials.

## Related Documents

- [483 - 2019-01-22](https://www.globalkeysolutions.net/records/483/specgx-llc/8d977356-1fa5-4bb4-8b75-131d999af26f)

## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)

Company: https://www.globalkeysolutions.net/companies/specgx-llc/715bb75a-8d3a-4469-9e6d-f617c2f39c93

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