FDA issues more warnings to Indian firms

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FDA issues more warnings to Indian firms

INICIO/Políticas y legislación | Posted 27/09/2013 0 Post your comment

The FDA is keeping up its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Posh Chemicals and Promed Exports for good manufacturing practice (GMP) violations.

FDA accused Posh Chemicals of changing data. Then, in the agency’s March 2013 inspection of the company’s plant in Hyderabad, FDA found problems such as failure to protect computerized data from unauthorized access, failure to ensure that test procedures were scientifically sound and failure to follow and document quality-related activities at the time they were performed.

Problems highlighted at the Promed Exports plant included failure to establish adequate systems for monitoring environmental conditions and for cleaning and disinfecting the room and equipment in aseptic processing areas. The agency also found that the company failed to thoroughly investigate unexplained discrepancies or failure of a batch or any of its components to meet specifications.

These are not the only Indian plants to receive warnings from FDA lately. In July 2013, both Fresenius Kabi and Wockhardt also received warning letters from FDA for violations at their Indian plants.

FDA stated that until all corrections have been made to its satisfaction it may withhold approval of any new drug applications from the companies.

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Source: FDA