The USFDA has also cautioned that unless corrective measures are taken up, it "may withhold approval of any new applications or supplements listing Fresenius Kabi, Kalyani as an API manufacturer".
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The USFDA warned that failure to correct the violations may result in ban of imports of products manufactured in the plant to the US.
In a letter to Mats Henriksson, president and CEO Fresenius Kabi AG — the parent firm of Fresenius Kabi Oncology — the USFDA said during inspections of the facility in January this year "investigator(s) from the USFDA identified significant deviations from current good manufacturing practice ( CGMP) for the manufacture of active pharmaceutical ingredients (APIs)".
"We have conducted a detailed review of your firm's response of February 11, 2013, and note that it lacks sufficient corrective actions," the letter added.
The letter cited a series of violations, including that the company kept some samples, data and results outside of the local systems for assessing quality raising serious concerns regarding the integrity and reliability of the data generated at the company's Kalyani plant.
"During the inspection your firm also repeatedly delayed, denied, limited or refused to provide information to the FDA investigators," it said.
The health regulator further said the company "failed to establish an effective corporate and local system for managing quality which would include the appropriate organisational structure, procedures, processes and resources, as well as activities to ensure confidence that all APIs produced by your facility will meet the intended specifications for quality and purity."
Recommending hiring of an independent third party auditor, the USFDA asked the company to provide corrective action plan that describes commitment, procedures, actions, and controls to ensure data integrity.
"This plan should include the corrective actions implemented to ensure that all managers, supervisors, quality unit personnel and other staff are properly trained in detecting data integrity and manipulation," it added.
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