Australian API Manufacturer Hit for Quality Failures

July 31, 2018

The FDA issued a Form 483 to active pharmaceutical ingredient manufacturer IDT Australia citing quality shortcomings and other deviations observed during a December inspection of its Boronia, Victoria, facility.

The investigator found multiple problems with the firm’s quality unit stemming from a lack of qualified personnel. For example, the firm failed to complete numerous tasks within required timeframes, such as closing out a laboratory investigation report for an out-of-specification assay and completing a temperature mapping report.

Additionally, the firm lacked adequate analytical procedures. It had no written procedures for test injections and chromatography data revealed examples “too numerous to count” of unprocessed and unreported injections that were named “test” or something similar. Also, manual integration of chromatography was permitted at the facility, but there were no procedures¬† in place describing when manual integration should be done, how to do it and how to review it.

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