FDA cites GMP non-conformities at Fresenius Kabi oncolytic API plant in Kalyani, India
German generic drugmaker Fresenius Kabi has received a warning letter from the US FDA after an inspection in January 2013 revealed a number of Good Manufacturing Practice (GMP) non-conformities at the firm’s oncolytic API plant in Kalyani, India.
The latest letter comes around 18 months after the FDA sent the company a warning about a plant operated by its APP Pharmaceuticals facility for failing to maintain sanitary conditions in sterile production areas.
Fresenius said in an official statement that the observations in the latest warning letter related to ‘GMP non-conformities regarding manufacturing, documentation practices and data integrity’.
The company said it had ‘put production on hold at the plant in January’ and had made ‘significant progress in remedying the issues cited in the warning letter’ and the process of restarting manufacture at the facility had begun based on a detailed remediation action plan submitted to the FDA.
Fresenius Kabi also said that it ‘takes this matter very seriously and intends to comprehensively respond in a timely manner’.
The company confirmed its financial forecast for 2013, which includes expected one-time charges to correct the issues cited by the FDA in its warning letter.