Fresenius Kabi Oncology Ltd.

An Indian drug manufacturer has agreed to pay $50 million in fines and forfeitures, the US Department of Justice announced Tuesday. Fresenius Kabi Oncology Limited (FKOL) plead guilty to concealing and destroying records; the charges came in the wake of a 2013 US FDA inspection of its plant in Kalyani, India. “By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for U.S. consumers,” said Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division in a press release announcing FKOL’s guilty plea. “FKOL’s conduct put vulnerable patients at risk. The Department of Justice will continue to work with the FDA to prosecute drug manufacturers who obstruct these inspections.” The offenses are federal misdemeanors. According to the Department of Justice and the FDA, FKOL systematically removed records and equipment from Kalyani plant premises in advance of a January 2013 FDA inspection. “Kalyani plant employees removed computers, hardcopy documents, and other materials from the premises and deleted spreadsheets that contained evidence of the plant’s violative practices,” according to the Justice Department announcement. After that inspection, the firm received a July 2013 warning letter from the FDA detailing the many irregularities observed by inspectors on their January visit to Kalyani. Among the problems found by the FDA was FKOL’s practice of blending failed batches of active pharmaceutical ingredients (APIs) with batches that had passed specifications, so that final tests for impurities would meet specification. Also, FKOL staff used test and “demo” chromatogram data files that were actually injected before the sample injections, and “used to conclude that batches were in conformance with the specification, said the FDA. “During the inspection your firm also repeatedly delayed, denied, limited or refused to provide information to the FDA investigators,” wrote the FDA, citing several examples of these practices in the letter. As noted in the Department of Justice filings against FKOL, equipment was removed from the facility in advance of the inspections, a finding also cited by the FDA in its warning letter: “You have also recently informed us that High Pressure Liquid Chromatography units and PCs were removed from the facility for the duration of the inspection to conceal data manipulations. This action, which apparently also occurred in association with past inspections, is very worrisome to us and should be explained in your response to this letter.” The Kalyani FKOL plant was cited again in a December 2017 warning letter for failure to investigate and document out-of-specification results; here, investigators found about 248 instances of aborted chromatographic sequences not justified by machine malfunction or other problems. The 2017 letter also found inadequate test procedures. Noting the deficiencies identified in the 2013 warning letter, the FDA said in 2017, “These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate.” RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information