FDA Warns Fresenius Kabi API Manufacturing Plant
The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi's active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies.
The warning letter, sent 18 December and following an eight-day inspection in April 2017, raises questions about Fresenius' failure to adequately address a sterility failure. FDA said the company's investigation into the sterility failure, which Fresenius attributed to laboratory error, "was deficient in that it did not sufficiently address these factors and thoroughly investigate potential manufacturing root causes."
FDA also noted that there were repeat failures at the site, and that during a previous inspection in May 2015, FDA cited a similar current good manufacturing practice (CGMP) observation in which the company invalidated sterility test failures "without adequately investigating the root causes, and failed to take timely and appropriate corrective actions."
Fresenius spokesman Martin Kunze told Focus the company has already responded to the warning letter.
"Production at the plant is continuing, three products using APIs from the Kalyani plant which are not on the FDA drug shortage list are supplied to the US, and we do not expect a change in the product supply, nor do we expect a material financial impact resulting from the warning letter," Kunze said.
He also noted that the company is working with outside consultants to cooperate with FDA and that 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. The APIs that were produced at Kalyani were within specification."