Fresenius Kabi Oncology fell afoul of the FDA in 2013 when the agency discovered employees had hidden records before a manufacturing inspection. Now, the drug ingredients manufacturer is admitting fault—and has reached a deal with the U.S. Department of Justice to put the investigation to bed.
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US health regulator USFDA has issued a warning letter to German drug firm Fresenius KabiBSE 0.26 % AG for lapses at its drug manufacturing facility at Baddi in Himachal Pradesh.
Fresenius Kabi Oncology Ltd Receives FDA Warning Letter
Most recently the use of ‘integration interruption’ capability of chromatography data systems has been identified as a means of data manipulation. In addition, some firms have gone to extremes in physically blocking the FDA’s access to areas which they have a right to inspect.
On January 19, 2016, Gland Chemicals Private Limited (Gland) secured Written Certifications of Exports to the European Union from the Central Drugs Standard Control Organization (CDSCO) for three (3) of its active pharmaceutical ingredients (APIs), including: