HYDERABAD: The US Food and Drug Administration (FDA), which inspected Aurobindo Pharmaceuticals Ltd’s manufacturing facility last month observed that documents provided during its inspection, were either incomplete or inaccurate or potentially misleading.
Aurobindo Pharma said on Monday that it received seven observations from the US health regulator for its unit-7 formulation plant in Telangana.
The US FDA had conducted a Current Good Manufacturing Practices (CGMP) inspection at the unit 7 manufacturing facility from September 19 to 27, 2019.
“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 throughout the inspection..,” noted the FDA inspection report.
It added that the corporate quality personnel who answered the questions were later found not to have undergone training on the apparent results investigation Standard Operating procedures (SOP).