The company’s site in Bavla underwent five-day inspection
India-based Dishman Carbogen Amcis, a global outsourcing partner for the pharmaceutical industry, announced that its manufacturing and development facility in Bavla has successfully completed an inspection by the US Food and Drug Administration (FDA).
The FDA’s Current Good Manufacturing Practices (CGMP) audit, which is performed to ensure proper design, monitoring and control of manufacturing processes and facilities, was held from October 22-26. The five-day inspection focussed on the Active Pharmaceutical Ingredient (API) units and ancillary areas of the Bavla site, specifically the quality system, production and packaging operations. The inspection also included examinations of the warehouses and quality control areas. No critical observations were reported and the final Establishment Inspection Report (EIR) is expected within the next six months.
“I am pleased with the positive outcome of this FDA inspection. It is the result of our ongoing dedication to maintaining high quality standards and continuously meeting our customers’ expectations,” said JR Vyas, Chairman and Founder, Dishman Carbogen Amcis Group.
“It was especially rewarding for us to hear that the auditor appreciated our teams’ open communication and transparent way of working. I am very proud of our staff. Their commitment to excellence every day is the key to our performance and our long track record of successful audits,” said Dr Himani Dhotre, CEO, DCAL Bavla site.
The Bavla facility manufactures products according to CGMP standards and is routinely inspected by legal authorities and external customers. The facility underwent successful FDA inspections in 2006, 2012, 2015 and 2016.
In operation since 1996, the Bavla facility is Dishman Carbogen Amcis’ main site and employs more than 900 people.