Inspectors from the US Food and Drug Administration (FDA) took Zydus to task over practices at its Moraiya, India facility in 2015. The warning letter accused Zydus of failing to investigate unexplained discrepancies and consumer complaints, putting it in violation of good manufacturing practices (GMP).
Now, the Moraiya facility is back in the FDA’s crosshairs. The FDA is yet to publish the warning letter but Zydus disclosed its existence in a filing with the Bombay Stock Exchange.
The lack of a public copy of the warning letter means it is currently unclear what failings led the FDA to take action against Zydus. Rather, all of the available information relates to what Zydus is doing to mitigate the impact of the regulatory action.
Zydus stated, “The company has taken multiple steps after the inspection to address the observations received from the FDA during the inspection. The company will continue to take all necessary steps to ensure that the FDA is fully satisfied with our remediation of the above facility. We are confident of responding to the FDA to address the observations within the statutory time permitted in the letter.”
Zydus said its existing business in the US is unaffected by the warning letter and it will continue to ship products from the Moraiya facility.
However, Zydus’ statement lacks information on whether there are pending approvals of drugs made at the facility. Warning letters can delay abbreviated new drug applications that are awaiting FDA approval, as happened to Zydus’ compatriot Strides Pharma Science earlier this year.
Strides and Zydus are part of a clutch of Indian drugmakers to receive FDA warning letters in recent months. The FDA published a warning letter covering Lupin’s plant in Mandideep at the start of last month and followed up with a notice about Glenmark Pharmaceuticals’ Baddi facility weeks later.
Such regulatory actions make headlines but Zydus has sought to communicate that other inspections pass without incident. In the statement to disclose the Moraiya warning letter, Zydus noted that its formulations manufacturing facility in Baddi and two active pharmaceutical ingredients plants have successfully completed inspections by the FDA this year.