# FDA 483 - Korex Chicago LLC - February 07, 2025

Source: https://www.keypedia.com/records/483/korex-chicago-llc/6e15f7ee-5a8a-4725-8ad0-2993789c4b93

> FDA 483 for Korex Chicago LLC on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Korex Chicago LLC
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Korex Chicago LLC, a drug manufacturer in Chicago, IL, was cited with six observations during an FDA inspection. The observations primarily concern significant deficiencies in microbiological control, cleaning validation, process control, stability testing methods, OOS investigations, and document control. These issues indicate a lack of robust quality systems and could impact drug product quality and safety.

## Related Officers

- [Travis V. Hull](https://www.keypedia.com/people/travis-v-hull/1f3b5843-29ed-4291-8a8a-a2bf3ac36988)
- [investigator](https://www.keypedia.com/people/nicholas-p-diorio/fba94f6f-38b9-4d30-b8a1-d6c9d4769e49)

Company: https://www.keypedia.com/companies/korex-chicago-llc/b5d1d2e5-a6a2-4153-ae0a-3a97b20df5de

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