Chromatography Institute of America dba Compounder’s International Analytical Laboratory

Warning LetterOpen

Mr. Ronald E. Sutton President & Owner Chromatography Institute of America dba Compounder’s International Analytical Laboratory 4760 Castleton Way, Suite A Castle Rock , CO 80109 United States rsutton@compounderslab.comFEI 3012069146Issued Aug 20, 2025Center for Drug Evaluation and Research (CDER)

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Letter Details

Firm: Chromatography Institute of America dba Compounder’s International Analytical Laboratory
Location: Mr. Ronald E. Sutton President & Owner Chromatography Institute of America dba Compounder’s International Analytical Laboratory 4760 Castleton Way, Suite A Castle Rock , CO 80109 United States rsutton@compounderslab.com
FEI Number: 3012069146
Country: United States
Issue Date: August 20, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Chromatography Institute of America, a contract testing laboratory in Colorado, was cited for significant Current Good Manufacturing Practice (CGMP) violations in its testing of active pharmaceutical ingredients (APIs) and finished drug products for human and animal use, rendering those drugs adulterated. During a February-March 2025 inspection, the FDA identified inadequate laboratory control mechanisms, specifically that the firm used identical methods and procedures across testing of APIs, outsourcing facility compounded products, and finished drugs without appropriate differentiation. The violations suggest the company failed to maintain adequate controls and procedures necessary to ensure the quality and safety of the products it tested.

Chromatography Institute of America dba Compounder’s International Analytical Laboratory FDA Warning Letter, August 20, 2025