Fresenius Kabi hit by second FDA warning letter
pharmafile | July 10, 2013 | News story | Manufacturing and Production | API, FDA, Fresenius Kabi, GMP
German generic drugmaker Fresenius Kabi has been sent another warning letter from the FDA citing deficiencies at a manufacturing plant.
The latest letter – focussing on an active pharmaceutical ingredient (API) facility in Kalyani, India – comes around 18 months after the US regulator sent the company a warning about a plant operated by Fresenius Kabi’s APP Pharmaceuticals facility for failing to maintain sanitary conditions in sterile production areas.
It also comes in the wake of a product recalls from the pharma company, including injectable benztropine mesylate and magnesium sulfate products which were contaminated by glass particles.
In a press statement, Fresenius Kabi said that the warning latter came in the wake of an inspection of the facility in January which revealed “GMP non-conformities regarding manufacturing, documentation practices and data integrity”. The letter has not yet been published on the FDA website.
The company said it placed production at the plant on hold following the inspection but “based on a detailed remediation action plan submitted to the FDA, Fresenius Kabi has begun the process of restarting manufacture at the facility”.
The facility – operated by Fresenius Kabi Oncology Ltd – makes a broad range of generic cancer APIs as well as other compounds such as anaesthetics and muscle relaxants.
It is one of the largest API facilities in the world involved in the manufacture of paclitaxel and irinotecan, but at the moment it is unclear whether the production halt has resulted in any shortages.
Neither irinotecan nor paclitaxel currently feature on the FDA’s list of current drugs in short supply, but other injectable cancer drugs such as leucovorin and doxorubicin have been under pressure of late owing to quality problems at manufacturing facilities and the withdrawal of some manufacturers from the market.
Kalyani is one of a pair of plants operated by Fresenius Kabi’s Indian subsidiary. The other is located at Baddi in Himachal Pradesh and focuses on finished dosage forms.
Fresenius Kabi said it would take a one-time charge this year as a result of the disruption to the Kalyani facility, but stressed this would not affect its financial forecasts for 2013.
Phil Taylor
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