Hyderabad: In yet another run-in with the US drug watchdog, city-based pharma giant Dr Reddy's Laboratories (DRL)'s plant-3 at Bachupally, Hyderabad, has now been issued with a Form 483 with 11 observations by the United States Food and Drug Administration (USFDA).
"We have been issued a Form-483 with 11 observations. These observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems. We will address them comprehensively within the stipulated time," DRL informed the bourses on Friday.
According to the USFDA, FDA Form 483 is issued to firm at the conclusion of an inspection when investigator has 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. Recently, USFDA had re-audited DRL's Duvvada unit in Visakhapatnam following which it had issued a Form 483 with 13 observations. Similarly, its API manufacturing unit at Miryalaguda in Telangana was issued a Form 483 with three observations post re-inspection. However, its Srikakulam API SEZ plant was cleared by USFDA with no observations earlier this month.
Source: The Times Of India