An active pharmaceutical ingredient (API) manufacturing plant of Dr. Reddy’s Laboratories in the U.S. has completed an U.S. Food and Drug Administration audit with a voluntary action indicated (VAI) classification.
The establishment inspection report from the USFDA for the API manufacturing plant at Middleburg, New York, has been received indicating closure of the audit, the company informed the stock exchanges on Wednesday night.
“The inspection classification of this facility is determined as Voluntary action indicated (VAI). Currently, we do not have any sales from this plant,” Dr. Reddy’s said.
In March 2021, the drugmaker had said following an audit of the plant the USFDA has issued a Form 483 with three observations. “We will address them comprehensively within the stipulated timeline. Currently, we do not have any sales from this plant,” it had then said.
The USFDA issues Form 483 to intimate the management of the objectionable conditions observed during inspection of a facility that may constitute a violation of the norms.
