Dr Reddy’s Laboratories (DRL) said that the US Food and Drug Administration (USFDA) has issued a Form 483 to its formulations manufacturing plant-3 at Bachupally in Hyderabad with 11 observations relating to deviations from good manufacturing practices (GMP) after inspecting the manufacturing plant.“The audit of our formulations manufacturing plant-3 at Bachupally, Hyderabad by the USFDA has been completed today. We have been issued a Form 483 with 11 observations,” Dr Reddy’s Laboratories said in a statement.
The observations by the drug regulator are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems, it added. “We will address them comprehensively within the stipulated time,” the drug firm said.
As per the USFDA, FDA Form 483 is issued to a firm at the conclusion of an inspection when the investigator has observed any conditions that in his or her judgment 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.