Last Updated on October 10, 2024 by The Health Master
In order to avoid delaying the approval of any pending product applications from the facility, Panacea Biotec Ltd. said that the US health regulator has requested additional corrective actions at the manufacturing facility of its wholly-owned arm in Baddi, Himachal Pradesh.
The US Food and Drug Administration (USFDA) inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma Ltd (PBPL) from May 30 to June 8, 2022.
Subsequently, the USFDA issued Form 483 with eight observations that are related to improvements in existing procedures and are addressable, Panacea Biotec said in a regulatory filing.
The US Food and Drug Administration (USFDA) states that when an inspector finds any conditions that could be considered violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, Form 483 is issued to the management of the company.
The company said it has “now received a communication from the USFDA indicating the inspection classification as Official Action Indicated (OAI)”.
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved, it added.
In the filing, it was stated that “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.”
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.
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