FDA spanks second Novacyl Asian API plant with warning letter

The FDA has cited a Novacyl active pharmaceutical ingredient (API) manufacturing plant in Thailand with a warning letter after finding some of the same issues there that it had uncovered at the company's facility in China.

The failings were laid out in a warning letter issued Feb. 27 and posted by the FDA today. Among other problems, the letter indicates the plant reprocessed 6 batches of APIs that initially failed specifications, adding in small quantities of passed ingredients, "until you dispensed the entirety of the rejected material" the letter said. It said another API batch had "insoluble black specks (dirt), size 5-10 microns" and was reprocessed and then marked as having met specs.

The inspectors found that the plant had not kept some data documenting quality and weight tests. "Your analyst selectively invalidated data during related substance testing," the letter said. The plant also did not have controls in place to assure that employees were not deleting data of failed tests.

The letter noted that the issues were similar to those laid out in a December warning letter to the Novacyl Wuxi Pharmaceutical site in Wuxi, Jiangsu, China. In that warning letter, inspectors reported finding failed test results in the trash and testing data that had been overwritten in testing equipment. The agency said the company was also changing integration parameters for an impurities test without documentation or justification.

In the latest letter the FDA told Novacyl it needed to "immediately undertake a comprehensive evaluation of global manufacturing operations of all your facilities to ensure compliance with CGMP expectations."

- here's the latest Novacyl warning letter

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