FDA Cites New Zealand Firm for Multiple Violations

May 18, 2018

The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland.

The agency called out the company for failing to thoroughly review unexplained discrepancies. For example, according to the Form 483, the facility did not initiate timely investigations after finding bacterial contamination in laboratory investigations. The investigations and corrective actions were not initiated promptly after the contamination was discovered and the production batches were not fully identified or evaluated.

The firm also used equipment that was not suitable for its intended uses. The agency noted that a system at the facility had a long section of piping between the micron filter and distribution loop that experienced stagnation. Another section of piping was ignored during routine sanitization.

The investigator also found the firm did not adequately clean all equipment and it lacked procedures to make sure a certain piece of equipment could be thoroughly cleaned and validated for cleanliness.

In addition, quality unit responsibilities were not fully followed. For instance, audit trail reviews did not ensure that the reviews covered all electronic data and a review of high-performance liquid chromatography data found areas of data that were never subject to evaluation.

The company also failed to exercise appropriate controls over computer systems to ensure only authorized employees could make changes to master production and control records.

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