Natco Pharma Kothur Unit USFDA Status
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Natco Pharma's Kothur unit in Hyderabad receives 'voluntary action indicated' classification from the USFDA after inspection.
New Delhi, Sep 18 (PTI) Natco Pharma Ltd on Thursday said it has received an establishment inspection report from the US health regulator for its Kothur unit in Hyderabad, classifying the facility as voluntary action indicated'.
The US Food and Drug Administration (FDA) had conducted an inspection at the company's pharma division located in Kothur, Hyderabad, Natco Pharma said in a regulatory filing.
The unit has now received Establishment Inspection Report (EIR) classifying the facility as "Voluntary Action Indicated (VAI)", it added.
Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
The US Food and Drug Administration (FDA) had conducted an inspection at the company's pharma division located in Kothur, Hyderabad, Natco Pharma said in a regulatory filing.
The unit has now received Establishment Inspection Report (EIR) classifying the facility as "Voluntary Action Indicated (VAI)", it added.
Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
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