Homehealthcare News

    US health regulator asks Panacea Biotec to take corrective measures at Himachal unit

    US health regulator asks Panacea Biotec to take corrective measures at Himachal unit

    US health regulator asks Panacea Biotec to take corrective measures at Himachal unit
    Read Time
    2 Min(s) Read
    Profile image

    By CNBCTV18.com  IST (Published)

    Mini

    Panacea Biotec stated in a regulatory filing that the USFDA has issued Form 483 with eight observations that are related to improvements in current practices and are solvable.

    Panacea Biotec said that the US health regulator has ordered additional corrective measures at its wholly-owned arm's production plant in Baddi, Himachal Pradesh, in order to avoid withholding clearance of any pending product applications from the site.
    From May 30 to June 8, 2022, the US Food and Drug Administration (USFDA) inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma Ltd (PBPL). Panacea Biotec stated in a regulatory filing that the USFDA subsequently issued Form 483 with eight observations that are related to improvements in current practices and are solvable.
    According to the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.
    The company said it has "now received a communication from the USFDA indicating the inspection classification as Official Action Indicated (OAI)".
    The company further added in the filing that the USFDA may delay approving any pending product applications or supplements submitted from this facility until the unresolved observations are addressed, as implied by the OAI classification.
    "PBPL is closely collaborating with USFDA to close these observations and the closure of the warning letter issued by the USFDA earlier on September 24, 2020," said Panacea Biotec.
    The warning letter was issued for non-compliance with the current good manufacturing practice outlined by the USFDA. It further said PBPL continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility.
    Shares of Panacea Biotec closed in the red today at Rs 138, falling 0.22 percent from the previous close on the BSE.
    (With inputs from PTI)
     
    Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!
    arrow down

      Most Read

      Market Movers

      View All
      CompanyPriceChng%Chng