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The US Food and Drug Administration (USFDA) has issued a warning letter to Aurobindo Pharma on its unit XI.
Aurobindo’s scrip lost 3 per cent on the Bombay Stock Exchange and is trading at Rs 592.65 on the Bombay Stock Exchange on Wednesday.
``Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated,’’ the US Regulator said in its warning letter sent to the Hyderabad-based Aurobindo Pharma.while citing relevant sections in its Act.
The warning letter is centered on the issue of the manufacture of Valsartan API.
The USFDA had directed Aurobindo Pharma ``to conduct a thorough review of all batches of API made at Aurobindo that shows unknown impurities above the reporting thresholds,’’ to identify any impurities beyond permitted levels.
The company also has to provide a thorough, independent assessment of its overall system for investigating unknown peaks, deviations, discrepancies, out-of-specification (OOS) results, complaints, and other failures.
``In addition, provide a retrospective review of all distributed batches within expiry to determine if your firm released batches that did not conform to established specifications, official compendium, or appropriate manufacturing standards,’’the letter said.
Earlier, three of Aurobindo's units, Unit I, Unit IX and Unit XI, had received an official action indicated status from the USFDA in May. Now, the US regulator had downgraded Unit XI with a warning letter.
The USFDA had also mentioned few repeat observations at multiple sites and cited similar CGMP observations at other facilities in the letter.
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