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MicroConstants Completes FDA Inspection

No observations or recommendations reported

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By: Tim Wright

Editor-in-Chief, Contract Pharma

MicroConstants, a bioanalytical and pharmacokinetic specialty CRO, has successfully completed a five-day inspection by the FDA for compliance with GLP regulations. The FDA inspected the company’s San Diego facility for overall GLP compliance and assessed lab areas and several method validations, three sample analysis projects, and a pharmacokinetic analysis report. The investigator reported zero findings, observations, or recommendations.

“MicroConstants aims to have one of the most comprehensive quality assurance programs in the industry,” said Jose Buenviaje, vice president of quality assurance and regulatory compliance at MicroConstants. “Annual examinations of our QA programs and bi-annual client surveys allow us to continually evaluate our current quality systems. This FDA inspection further confirms the quality of GLP-compliant services performed by MicroConstants.”

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