The Duvvada (Visakhaptanam) sterile injectables facility of drug major Dr Reddy's Laboratories Limited has again been issued a Form 483, this time with 8 observations, by the team of US Food and Drug Administration(USFDA) at the end of the reinspection conducted at the request of the company.
"The audit of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the USFDA, has been completed today. We have been issued a Form 483 with 8 observations, which we are addressing," the company said in a filing.
The fresh round of concerns raised by the USFDA inspectors over the Oncology formulations facility comes