Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA
"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," the USFDA inspection report said in one of the observations for Aurobindo Pharma facility.
New Delhi: The US Food and Drug 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 throughout the inspection," the USFDA 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 reports further said.
Reacting to the USFDA observations, Aurobindo Pharma had earlier said, "The inspection ended with 7 observations. We believe none of the observations is related to data integrity. The Company is confident in addressing these issues within the stipulated timeline."
The USFDA conducted a cGMP (Current Good Manufacturing Practices) inspection at the Unit 7 manufacturing facility from September 19-27 this year.
The USFDA recently issued a warning letter to Aurobindo Pharma's Unit X1 (Active Pharmaceutical Ingredients (API) in Srikakulam District of Andhra Pradesh for deviations from CGMP.
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