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•Materials Characterization Center Inc•October 7, 2025

FDA 483 - Materials Characterization Center Inc - October 07, 2025

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Record Details

An FDA inspection of Materials Characterization Center Inc in San Juan, PR, revealed significant deficiencies in computer system controls for laboratory analytical equipment. The firm failed to ensure that changes to records were instituted only by authorized personnel, lacking unique user access, audit trails, and proper privilege management for analytical software. These issues could compromise the integrity of drug product analysis data submitted to customers.

Company
Materials Characterization Center Inc
Inspection Date
October 7, 2025
Product Type
Drugs
Office
San Juan District Office
Person
  • Alan A. Rivera
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ID · 24777a0a-44b0-4cab-9cc8-5c2cbdaac72c

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