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    Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-10-11T10:00:59+05:30  |  Updated On 2021-08-16T12:09:26+05:30

    "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.


    Read Also: Aurobindo Pharma rises 5 pc post clarification on USFDA observations for Unit-7


    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.


    Read Also: Aurobindo Pharma Unit-7 gets 7 USFDA observations

    active pharmaceutical ingredients API aurobind pharma Srikakulam facility Aurobindo Aurobindo Pharma aurobindo pharma telangana facility aurobindo pharma unit7 BSE cGMP pharma pharma company pharma news pharma news india US Food and Drug Administration US health regulator USFDA USFDA warning 
    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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