# FDA 483 - SpecGx LLC - January 22, 2019

Source: https://www.keypedia.com/records/483/specgx-llc/8d977356-1fa5-4bb4-8b75-131d999af26f

> FDA 483 for SpecGx LLC on January 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecGx LLC
- Inspection Date: 2019-01-22
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Spec Gx LLC, an API manufacturer in Greenville, IL, was cited for failing to document a required inspection on batch records. Inspectors found that four out of six reviewed Compap Coarse L batch production records lacked documentation of a critical inspection, despite these lots being reviewed by quality and manufacturing and subsequently released for distribution. This indicates a breakdown in adherence to established quality control procedures and documentation practices.

## Related Documents

- [483 - 2026-02-27](https://www.keypedia.com/records/483/specgx-llc/1114cee7-20e5-4785-b5c5-5f8988e4a98c)

## Related Officers

- [Kara L. Roden](https://www.keypedia.com/people/kara-l-roden/72d96288-086a-4be4-a024-0aaf89948eb8)

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

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