Fresenius Kabi is taking seriously the FDA's allegations that staff at an Indian API plant lied to investigators and concealed data, and the generic drug unit of the German healthcare giant said it has fired the workers responsible.
A company spokesman told in-Pharmatechnologist.com that the behavior cited in an FDA warning letter made public this month blatantly violates Fresenius Kabi's manufacturing standards and that the company immediately replaced all of the plant's managers and each of the workers implicated.
In the warning letter, the FDA details attempts at secrecy worthy of the Keystone Cops, with one employee trying to hide test results by shoving them into his pocket in full view of inspectors and others throwing out high-pressure liquid chromatography equipment and computer terminals to conceal previous data manipulations.
Fresenius Kabi has already submitted a remediation plan to the agency, the company said, bringing in third-party auditors to oversee its efforts and avoiding further punitive action from the FDA.
The generics outfit said the problems with its Indian plant will result in a one-time charge of an unspecified amount, and the company is sticking to its expectation of 7% to 12% earnings growth on the year.
The Indian issue is Fresenius Kabi's second warning letter in 18 months, following an incident in which FDA inspectors found insects in the sterile manufacturing area of a Grand Island, NY, plant operated by the company's APP Pharmaceuticals subsidiary.
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