“This is to inform you that the audit of our formulations manufacturing Plant - 3 at Bachupally, Hyderabad by the USFDA, has been completed on Friday. We have been issued a Form 483 with 11 observations. We will address them comprehensively within the stipulated timeline,” the company informed the bourses.
In fact, the same unit was issued 11 observations by USFDA in April 2017. But then the company had stated that the observations were mostly procedural in nature, reflecting the need to improve people’s capabilities and strengthen documentation and laboratory systems.
As per the USFDA website, an FDA Form 483 is issued to a firm at the conclusion of an inspection wherein investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company’s management of objectionable conditions.
In January this year, its API manufacturing plant in Miryalaguda, Telangana, too was issued a Form 483 with one observation and before that its Srikakulam Plant in AP too was issued a Form 483 with four observations by FDA.