The FDA issued Australian contract OTC drugmaker Tismor Health and Wellness a warning letter for serious GMP violations and data integrity lapses.
An agency inspection of the facility in New South Wales found that the firm lacked adequate data controls for the gas chromatography instrument used to test products before release, allowing administrator privileges for analysts conducting routine tests.
A review of the chromatography audit trail found that the firm had deleted more than 100 test results since October 2017 and aborted more than 100 sample test results, but failed to carry out investigations.
The FDA noted that the firm’s proposed fix for the problem would still allow analysts to perform “trial work” which would be kept in a separate folder. The agency called this “an unacceptable practice,” adding that “it is essential that all data from the analysis of drug samples be retained and reviewed.”