- The Food and Drug Administration has slapped Fresenius Kabi AG with its second warning letter in less than a month, criticizing the German drugmaker for improperly examine sterility issues at one of its manufacturing facility in India.
- During an April 2017 inspection of the facility, which is located in the town of Baddi, the FDA observed microbial growth in media canisters for a lot of drug product and determined Fresenius failed to adequately investigate the root cause of the contamination.
- Regulators noted similar issues during a May 2015 inspection of the site, leading them to conclude in their Dec. 18 warning letter that Fresenius' "oversight and control over the manufacture of drugs remains deficient."
The FDA has taken issue with how Fresenius investigates production problems at its manufacturing sites for several years now.
In 2013, for instance, the agency sent a warning letter to the company because of deviations from current good manufacturing practices (CGMPs) that led to adulterated active pharmaceutical ingredients (APIs) at its plant in Kalyani, India. Regulators highlighted how "[o]ut-of-specification or undesirable results were ignored and not investigated."
The Kalyani plant came under fire from the FDA again last month. A new warning letter explained that Fresenius still wasn't adequately investigating out-of-specification results, nor were its procedural tests robust enough.
Over in Baddi, a similar problem has taken hold.
"According to your investigation, the most probable root cause was laboratory error," the FDA wrote in its Baddi warning letter, referring to a Fresenius investigation into sterility problems for a lot of drug product.
"Specifically, your May 10, 2017, response states that an analyst failed to immerse sterility test sample vials and other materials in sporicidal solution before transferring them from the Grade C to the Grade B sterility testing room. Instead, the analyst performed a spray disinfection. You indicated that spraying with a sporicide will disinfect the top and sides of samples, but that the bottom of units might not be fully decontaminated."
Fresenius maintains that improvements are being made and that the warning letters haven't dramatically affected its ability to produce drug product.
"Our quality system did, indeed, investigate the out of specification test results, but the FDA believes we should improve our investigations. And we are fully committed to do so," a spokesperson told BioPharma Dive via email, adding that the drugs produced at Baddi met release specifications and that the FDA's inspections haven't brought about any product recalls or other field safety corrective actions.
"Three products manufactured in the Baddi plant and using APIs from the Kalyani plant — which are not on the FDA drug shortage list — are supplied to the U.S., and we do not expect a change in the product supply, nor do we expect a material financial impact resulting from the warning letter," the spokesperson said.