Generic and API firms get latest crop of FDA warning letters
pharmafile | May 10, 2011 | News story | Manufacturing and Production |Â Â Cephazone, FDA, FDA warning letter, Ningbo Smart, TevaÂ
Generic drugmakers Teva and Cephazone and API producer Ningbo Smart are the latest companies to receive warning letters from the US regulator for GMP violations.
Generic drugmaker Teva Pharmaceutical Industries may have resolved quality issues at a manufacturing facility in Irvine, California, but still has some work to do at another plant in Israel, according to an FDA warning letter.
The letter – dated 31 January but only recently posted on the FDA website – centres on a failure by the company to properly investigate a batch of an unidentified drug product which was out-of-specification because of excessive levels of impurities. The product was eventually released based on test results from a different analysis.
Other issues cited in the letter include a lack of investigation of contamination with black particles in another product and other-out-of-specification quality results, and a failure to establish separate or defined areas of the Petach Tikva plant to prevent contamination or mix-ups during drug manufacturing.
Cephazone Pharma of the USA has been sent a warning letter by the FDA for failing to test batches of drug products, including the injectable antibiotic ceftriaxone, for sterility. The letter dated 25 April comes in the wake of inspections of the generic drugmaker’s manufacturing facility in Pomona, California, in July and August 2010.
The FDA also cites Cephazone for not establishing written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, as well as an overall failure to draw up suitable specifications, standards, sampling plans, and test procedures to ensure drug product “identity, strength, quality, and purity”.
Cephazone also failed to put IT procedures in place to monitor production and control records and make sure changes can only be made by authorised personnel, said the agency in its letter. The cephalosporin antibiotics specialist is a joint venture between India’s Aurobindo Pharma and US veterinary antibiotics firm Med-Pharmex.
Chinese active pharmaceutical ingredient manufacturer Ningbo Smart Pharmaceutical Co was sent a warning letter dated 30 March for not properly testing batches of API before the material was shipped to customers. The company also failed to carry out identity testing of all incoming raw materials, and has not registered all APIs distributed in the USA with the FDA, according to the letter.
Ningbo Smart has also fallen foul of regulators in Europe of late. The European Directorate on the Quality of Medicines & Healthcare (EDQM) recently withdrew certificates of analysis (CEPs) for two of the company’s APIs, namely diclofenac sodium and mefenamic acid.
A CEP is awarded by the EDQM if a company provides a declaration that it is making ingredients in accordance with Good Manufacturing Practice (GMP), and does not depend on a pre-approval inspection.
Phil Taylor
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