The US Food and Drug Administration (FDA) issued the letter last month, detailing observations made by inspectors who visited the plant in Kalyani, West Bengal in May last year.
The agency's concerns relate to out-of-spec (OOS) results: firstly, that Fresenius did not fully investigate such occurrences during the audit; and secondly that operators halted analyses likely to return OOS results and attributed the deviations to human or machine errors.
The FDA said the failings – combined with similar deviations detailed in a letter in 2013 – indicate the “facility’s oversight and control over the manufacture of drugs is inadequate.”
It suggested Fresenius hire a consultant to bring the facility up to code.
The agency also urged the firm to initiate a comprehensive assessment of all of its manufacturing operations to “ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements."
A Fresenius representative told us, “The observations are related to documentation procedures for out of specification results as well as to procedures for analytical testing. The purely analytical tests were aborted due to technical reasons.”
He added that, “The APIs that were produced at Kalyani were within specification.”
The Kalyani facility makes APIs for liquid pharmaceutical products, including injectable cancer drugs. According to the representative, three products using APIs made there are supplied to the US.
He added that, “We do not expect a change in the product supply, nor do we expect a material financial impact resulting from the warning letter” going on to say Fresenius had dedicated significant resources including external consultants to address the FDA’s concerns.
The representative said, “We have already submitted our answer to the FDA and will provide the FDA with detailed information and more evidence to allow the agency to fully assess the adequacy of our corrective actions. We are convinced we will resolve the issues according to the FDA's expectations.”