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.