USFDA grants EIR to close inspection at Dishman's Bavla Manufacturing Facility
The inspection conducted by the United States Food and Drug Administration (US FDA) at Dishman Carbogen Amcis Ltd's facility in Bavla, Ahmedabad, which was scheduled from March 4 to March 8, 2024, was successfully completed on March 7, 2024.
The inspection concluded with several procedural observations, which will be addressed within the established timelines. It is noteworthy that no significant issues were identified throughout the inspection process. The USFDA granted Dishman the Establishment Inspection Report (EIR) to close the inspection.
Consequently, the company’s facilities in both Bavla and Naroda in India, as well as its multiple facilities in Switzerland and the Netherlands, continue to maintain approval from the US FDA.
Dishman’s Chief Operating Officer, Mr. Paolo Armanino stated, “The USFDA approval adds tremendous value to the Dishman brand. Respected across the world, the USFDA accreditation instils a sense of great accomplishment and illustrates the quality of our standards, operations, and processes. To see our efforts come to fruition after a complex yet rewarding journey makes us very proud.”
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