# FDA 483 - Compounders International Analytical Laboratory - March 05, 2025

Source: https://www.globalkeysolutions.net/records/483/compounders-international-analytical-laboratory/10ad2821-24ca-49ae-9087-216d5b1508a4

> FDA 483 for Compounders International Analytical Laboratory on March 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compounders International Analytical Laboratory
- Inspection Date: 2025-03-05
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Chromatography Institute of America, Inc. in Castle Rock, CO, a contract testing laboratory, was cited for numerous significant quality control and laboratory control deficiencies. These include inadequate OOS investigations, lack of validated procedures for sterility testing and media, poor data integrity controls, and a complete failure to maintain a complaint log. The findings indicate systemic issues across quality assurance, laboratory operations, and data management.

## Related Officers

- [Director of Compliance Branch](https://www.globalkeysolutions.net/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/compounders-international-analytical-laboratory/411507bf-e913-4095-b18c-322b9cbcc686

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face