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# CGMP Deviations at Miami University Contract Lab
- URL: https://www.fdaweb.com/cgmp-deviations-at-miami-university-contract-lab/
- Published: 2022-05-03T12:00:00.000Z
- Updated: 2026-09-14T17:43:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151730

An 11/1-11/5/21 FDA inspection at a contract testing laboratory operated by the Miami University Department of Chemistry and Biochemistry, Oxford, OH, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A 4/20 Warning Letter says specific deviations were: 

- failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failing to have adequate controls to prevent omission of data;
- failure of the quality unit to ensure that drugs are appropriately tested and the results are reported; and
- failing to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the particular operations that each employee performs and CGMP as they relate to the employee’s functions.

The letter says that based on the nature of the deviations, FDA recommends that the lab engage a qualified consultant to assist it in meeting CGMP requirements. FDA acknowledges that the university committed to cease trace metal analyses and suspend testing of APIs at the facility. The lab was asked to clarify whether it intends to resume testing any drugs in the future and was told to contact FDA before resuming any testing. It was also told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrective actions.