FDA warns Fresenius Kabi over plant problems
pharmafile | August 27, 2013 | News story | Manufacturing and Production |Â Â FDA, Fresenius, kabi, recallÂ
German drugmaker Fresenius has been sent another warning letter by the US Food and Drug Administration, this time for a plant in Puerto Rico operated by its Fresenius Kabi subsidiary.
The letter – the third received by Fresenius since the start of the year – was prompted by an April inspection of a blood bag manufacturing unit in Maricao that was acquired along with Fenwal, a company which Fresenius bought towards the end of 2012 for an estimated $1 billion.
The company says the observations that prompted the warning are related to complaint-handling procedures, labelling issues, and the filing of field alerts not in accordance with FDA regulations.
No patient safety issues have been raised by the agency, and production at the plant is continuing as before, according to Fresenius, which said its forecasts for Fresenius Kabi remain unchanged.
In July, the FDA also sent Fresenius a warning letter raising questions about the ‘integrity and reliability’ of quality control functions at its Kalyani facility in Nadia, West Bengal, noting that some testing results were unreported, while retests were carried out without explanation.
“Only passing results were considered valid, and were used to release batches of active pharmaceutical ingredients (APIs) intended for US distribution,” according to the letter, which also noted that failing batches were blended with passing batches in order to meet specifications, indicating ‘poor quality governance’.
An employee at the Kalyani facility, which supplies cancer drug ingredients, was also observed hiding test results in his pocket while others admitted to falsifying and concealing data, according to the warning letter.
In March, Fresenius’ dialysis subsidiary Fresenius Medical Care also fell foul of the FDA for failing to carry out proper procedures in the sterilisation of dialyser equipment, and the company has also been forced to recall various products because of glass contamination in vials.
Fresenius said in a statement that it “takes this matter very seriously and intends to respond in a timely and comprehensive manner to the warning letter”.
Phil Taylor
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