Sontec Instruments Cited for Design History, Other Violations
Sontec Instruments was cited in a Form 483 for failing to establish unique design history files, failing to adequately document design verification results, and other violations.
During an October 2016 visit to the firm’s Contennial, Colo., facility, the FDA inspectors found that the design history file did not demonstrate that the design was developed following regulatory requirements. Specifically, Sontec holds a 510(K) for Class II medical devices in seven general categories, including clamps, forceps, knot tiers, needle holders, knot pushers, scissors and suction tips. But the company failed to establish unique design history files for each type of device.
Inspectors also reported that design verification results, including the identification of the design, the methods, the date and the individuals performing the verification, were not adequately documented in the design history file. There was no documentation for the design verification of certain specifications for several types of needle holders as required by Sontec’s standard operating procedures. — Jeff Kinney