Date: 11-Oct-2019

Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA

Administration officials who inspected a manufacturing facility of Aurobindo Pharma have observed that several documents, provided during the inspection, were incomplete or inaccurate or potentially misleading. Aurobindo, on October 7 said it received seven observations from the US health regulator for its unit-7 formulation plant in Telangana. "The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either provided as incomplete, inaccurate and or explained with potentially misleading statements through out the inspection," the FDA inspection report said in one of the observations. "The corporate quality personnel who answered our questions were later found not to have undergone training on the apparent results investigation SOP," it said. Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product, it's report further said.