FDA warning letter due to non-compliance with specifications and ID testing

This FDA warning letter issued to Australian drug and active substance manufacturer IDT Australia Ltd. on 23 May, 2018 is based on an FDA inspection which took place in December 2017.

The FDA particularly criticised that not all results from the analytical laboratory had been reported. This had been the case on several occasions in various parts of the company.

During the testing of a batch, three consecutive identity tests had failed. The forth test had been within specifications, and only this result had been reported. The three failed tests had not been forwarded to the Quality Unit and had therefore not been included in the authorisation application which was submitted for this product. At the time of the inspection, they hadn't been aware of the lab technician not having reported the failed results.

Moreover, the out-of-specification (OOS) results of assay determinations had not been investigated, and no corrective measures had been initiated. Several batches of active substances and finished medicinal products had been released for the market by the Quality Unit without the root causes of the OOS results being identified.

IDT Australia Ltd. told the FDA in their response that the batches released subsequently had been in compliance with the specifications and that the analytical trends were compliant with the before manufactured batches. However, they couldn't produce any data to support their claim.

As a response to this warning letter, the FDA now expects the following of IDT Australia:

  • A detailed summary of all performed investigations,
  • A risk assessment for the batches which had been released without the root causes having been determined,
  • Additional samplings and tests for a period of more than two years to support issued releases,
  • A global action plan determining a deadline for when all corrective measures must be concluded.

The complete FDA warning letter to IDT Australia Ltd. can be viewed here.

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