IDT Australia Inspection Finds Multiple CGMP Issues

A 12/4-12/8/17 FDA inspection at IDT Australia, Boronia, Victoria, Australia, found current good manufacturing practice (CGMP) regulations deviations in the firm’s manufacturing of active pharmaceutical ingredients (API) and violations in its manufacturing of finished pharmaceuticals. A 5/23 Warning Letter says the API deviations were: 

•          failing to adequately investigate out-of-specification results and implement appropriate corrective actions; and
•          failure of the quality unit to ensure that critical deviations are investigated and resolved.

The specific finished pharmaceutical violations were: 

• ·        failing to establish and follow adequate required laboratory control mechanisms, including any changes made to them that were drafted by the appropriate organizational unit and reviewed and approved by the quality control unit;
•          failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards; and
•          failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and the authority to review production records to assure that no errors have occurred, or if errors have occurred, that they have been fully investigated.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. “We strongly recommend that you retain a qualified consultant to assist in your remediation.” The company was told to provide (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a firm management strategy that includes details of its global corrective and preventive action plan.

IDT also was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.