Kanteron Systems USA passes FDA inspection without issues
On April 25th Kanteron Systems had its first routine FDA (U.S. Food and Drug Administration) Medical Device Establishment Inspection.
Agent (Investigator) Kimberley A. Ricketts gave us a routine “Notice of Inspection pursuant to Section 704(a)(1) of the Federal Food, Drug, and Cosmetics Act [21 U.S.C. 374(a)] and Part F or G, Title III of the Public Health Service Act [42 U.S.C. 262-264]“. This Level 1 inspection was conducted as part of the NYK-DO Work Plan under FACTS ID#1456352 in accordance with Compliance Program 7382.845.
After going over all kinds of documentation: quality management system, customer communications, installations, development processes, feedback, auditing, security, bugs, reports… the inspection was finished May 13th without the issuing of any FDA-483, which means the inspection was closed (under 21 C.F.R. part 20.64 (d) (3) and with an EIR in accordance to the FOIA and 21 C.F.R. part 20) with a final report stating that everything is correct and we can continue to operate.