Australian API and generics maker hit with US FDA warning letter

07-Jun-2018 - Last updated on 07-Jun-2018 at 13:57 GMT

(Image: Getty/SBphotos)

Analytical testing concerns and ‘inadequate’ investigations into failed results were among the GMP deviations observed by the US FDA at IDT Australia Limited’s facility.

The US Food and Drug Administration (FDA) has issued a warning letter to the Australian pharmaceutical company and contract development and manufacturing organisation (CDMO) IDT Australia, following an inspection of its Boronia facility, Victoria, in December last year.

According to the FDA, IDT Australia – which makes active pharmaceutical ingredients (APIs), and finished drug products for clients – failed to ‘adequately’ investigate out-of-specification (OOS) results at its facility.

In one particular instance regarding API manufacture, a failed result prompted an OOS investigation, but “concluded, without adequate evidence, that a biohazard cabinet was a potential source of contamination and released the batch,” said the FDA. “The root cause you identified lacked scientific justification.”

A lack of adequate laboratory control mechanisms was also flagged among good manufacturing practice (GMP) violations for finished drug products.

“Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards,” observed the FDA. “Our review of your laboratory records revealed that you failed to report non-conforming test results on multiple occasions in multiple parts of your operations."

According to the letter, the firm’s analytical testing procedures were also of concern.

When batch testing in 2016, three consecutive identity test failures occurred, said the FDA: “The fourth test passed and you reported this conforming result.”

However, IDT Australia “did not include the three failures in the data package submitted to the quality unit for review of your application submission for this product,” said the US regulator.

Further, the firm “did not conduct an investigation into the non-conforming results. At the time of the inspection, you were unaware that your analysts had not reported the failing results to your quality unit for review."

The FDA has ‘strongly’ recommended the company work with a consultant to remediate these issues.

The news comes one month after IDT Australia announced plans to divest a number of generic candidates from its portfolio, in order to focus on its commercial API and contract manufacturing business.

IDT Australia did not respond to a request for comment.