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Miami University's Department of Chemistry and Biochemistry, operating as a contract testing laboratory for pharmaceutical ingredients including heparin, failed to maintain adequate controls over computerized systems to prevent unauthorized data access, changes, or omission of records. The facility's testing operations—which included elemental impurity and identity testing—did not conform to current good manufacturing practice (CGMP) standards, resulting in adulterated active pharmaceutical ingredients. The FDA inspection from November 1-5, 2021, identified significant deviations in data integrity controls that rendered the laboratory's API products non-compliant with federal manufacturing requirements.