The US health regulator has issued a warning letter to the Drug firm Divis Laboratories at Visakhapatnam. However, the company along with few external consultants and subject matter experts are trying to work to address the concerns of the United States Food and Drug Administration (USFDA) and is striving to fully meet the compliance requirements. The company has reportedly not provided the details of the warning letter.
The company said that the laboratories have responded to the USFDA inspection observations with a very appropriate remediation process to overcome the deficiencies which have been observed.
Earlier, when an import alert has been issued the regulator had exempted several products which are being manufactured at the Unit II in Visakhapatnam, said the Divis Laboratories. The exempted products include Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate.
However, the company will respond to this warning letter from the USFDA with a detailed plan within the stipulated time. It is also said that earlier, in a regulatory filing the regulator had issued import alert for products which are being made at Visakhapatnam unit citing violation of products made at Visakhapatnam unit citing violation of manufacturing norms and refusal of inspection.
Discussion about this post