Latest FDA warning letters cite Tedec-Meiji, BMP Pharma
pharmafile | May 28, 2012 | News story | Manufacturing and Production |Â Â BMP Pharma, FDA, Tedec-Meiji FarmaÂ
Spanish drugmaker Tedec-Meiji Farma and German active pharmaceutical ingredient (API) producer BMP Pharma both feature in the latest crop of warning letters published by the FDA.
In the case of Tedec Meiji, a subsidiary of Japanese pharma company Meiji Seika Pharma, an FDA inspection in July 2011 revealed significant GMP violations at the company’s facility at Alcala de Henares, Madrid, including a failure to investigate batch failures.
The plant manufactures products such as the non-steroidal anti-inflammatory drugs (NSAID) Bosporon Rapid (lornoxicam), antibiotic Meiact (cefditoren) and disinfectant Adaspor.
FDA inspectors uncovered delays in detecting out-of-specification lab results, averaging of analytical results in order to get a passing value, and a failure to expand the investigation into the failure to other batches that may have been affected.
Tedec-Meiji also fell down on another area which is currently attracting a lot of attention from the FDA and other regulators, namely a failure to check the quality of raw materials used in the manufacture of its products, relying instead on data from the supplier.
Other deficiencies noted by the FDA included a lack of scientifically-sound procedures to check the quality of products with regard to “identity, strength, quality and purity”, which could have impacted the quality of products, including material which was distributed in the US.
Tedec-Meiji responded to the findings in the inspection report last August, but the FDA said this lacked sufficient corrective actions.
Meanwhile, BMP Pharma’s Norderstedt facility in Germany failed an inspection by the FDA last November, with the agency staff noting a number of violations, including a failure to use dedicated production areas which could have allowed contamination of other products with beta-lactam antibiotics.
The letter orders BMP Pharma to cease all beta-lactam production until this issue is addressed and properly segregated production areas have been assigned. It also asks the company to detail plans for decontaminating the facility.
Phil Taylor
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