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USFDA Issues Warning Letter To RPG Life Sciences Ltd-Business Standard


Wednesday, 19 Jun 2013 11:34am EDT 

Business Standard reported that US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences Ltd for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai. The health regulator said in a letter posted on its website. During our November 20, 2012 through November 24, 2012 inspection of RPG Life Sciences Ltd pharmaceutical manufacturing facility, MS-Ankleshwar, investigator(s) from the FDA identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Likewise, during an inspection of the pharmaceutical manufacturing facility, at Navi Mumbai, investigators from the FDA identified significant deviations from CGMP for the manufacture of active pharmaceutical ingredients (APIs), it added. These violations cause RPG Life Sciences Ltd's APIs and drug products to be adulterated. The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP, USFDA said. 

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