United States Food and Drug Administration (USFDA) has issued a warning letter to Divis Laboratories’ Unit-II at Vishakhapatnam facility. The company along with external consultants and subject matter experts is working to address the concerns of USFDA and is making all efforts to fully meet the compliance requirements.
The company has responded to USFDA inspection observations with an appropriate remediation process to overcome the deficiencies observed.
Divis Laboratories focussed on developing new processes for the production of Active Pharma Ingredients (APIs) & Intermediates. The company in a matter of short time expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharmaceutical industry.