Switzerland-based Carbogen Amcis, a pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, has announced that its Bubendorf, Switzerland API manufacturing site has successfully completed a routine U.S. Food and Drug Administration (FDA) inspection.
The cGMP (current Good Manufacturing Practices) Audit was completed over five days, from September 4th to 8th, 2017. The inspection consisted of an analysis of all Quality Systems, processes and procedures related to the development, validation and manufacture of APIs and highly-potent APIs at the Bubendorf site. The inspection was concluded without major or critical observations or Form 483’s, thus confirming that no concerns were discovered during the inspection. The Final Establishment Inspection Report (EIR) is expected in the next six months.
“The successful FDA inspection of our Bubendorf site, proceeded by two successful inspections of our two other sites in Aarau and Neuland in 2015, reinforces our commitment to delivering the highest standard of quality that our customers expect from us,” says Mark Griffiths, CEO Dishman Group.
The Bubendorf facility manufactures products according to cGMP standards and is routinely inspected by SwissMedic, the FDA and external customers. The facility underwent successful FDA inspections in 2002, 2008, 2011 and 2014.