Chromatography Institute of America dba Compounder’s International Analytical Laboratory
FDA issued a warning letter to Chromatography Institute of America dba Compounder's International Analytical Laboratory (Castle Rock, CO), a contract testing laboratory serving 503B outsourcing facilities and other drug manufacturers, citing significant CGMP violations including inadequate laboratory controls, invalid sterility test investigations, and insufficient Quality Unit oversight. The firm was found to have adulterated drugs within the meaning of section 501(a)(2)(B) of the FD&C Act due to failures in microbiological testing, data integrity, and document control. FDA expressed concern about the validity and integrity of data provided to 503B outsourcing facilities and noted the firm communicated intent to shut down operations during the inspection. The letter warns that failure to remediate may result in seizure, injunction, withholding of export certificates, and blocking of new drug application approvals.
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and deviations and to prevent their recurrence.
If you plan to resume contract laboratory testing operations regulated under the FD&C Act, notify this office before resuming your drug testing operations.
Failure to address this matter promptly and adequately may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations and deviations are completely addressed and we confirm your compliance with CGMP.
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