Kanteron Systems’ New York office was inspected by the FDA on February 5th 2015 pursuant to FDA NYK-DO’s 2015 workplan under FACTS Assignment #11499178 in accordance to Compliance Program, Inspection of Medical Device Manufacturers, 7382.845 covering PAC’s 82845A.
The inspection covered Kanteron Systems’ operations. The QSIT inspection approach was used in conducting the QSR/cGMP covering the Corrective and Preventive Action and the Production and Process Control subsystems. No FDA 483 was issued.
The previous inspection was conducted May 13, 2013 and was classified NAI.
Almost simultaneously the Spanish Headquarters of Kanteron Systems passed the annual quality system EN ISO 9001:2008 audit by Bureau Veritas (BVQi), number 8001731 ENAC, without a single objection.
Congratulations to our QA team!