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USFDA issued warning letter to IDT Australia Limited's facility on account of GMP violations

Warning letter has been issued by USFDA to the Australian pharmaceutical company and contract development and manufacturing organization (CDMO) IDT Australia due to GMP violations. IDT Australia makes APIs and finished drug product s for clients. The company's Boronia facility, Victoria was inspected by FDA in December 2017.

Some of the GMP violations observed by the FDA inspectors were as mentioned below:

1) Failure to adequately investigate out of specification (OOS ) results at Boronia facility.
2) In a particular instance of API manufacturing, there was a failed resulted which prompted OOS investigation however the firm concluded that a biohazard cabinet was a potential source of contamination for which there was no adequate evidence and batch was released. FDA told the firm that the root cause given for releasing the batch lacked scientific justification.
3) Lack of adequate laboratory control mechanisms-According to FDA, “The firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. The data reviewed by FDA suggested that the firm’s laboratory records failed to report non-conforming test results on multiple occasions in multiple parts of firm's operations.
4) Improper analytical testing procedures-In a batch tested in 2016, it was found by FDA that three consecutive test failures occurred but the fourth test passed which was reported as conforming result, however the firm did not include the three failures in the data package submitted to the quality unit for review along with the application submission for the product. The firm even did not conduct an investigation into the non-conforming results and during FDA inspection, the officials found that was not aware that their analysts had not reported the failing results to the quality unit for review.

FDA has asked the firm to hire a consultant to have corrective and preventive action in place for the observations cited in the warning letter.