Editor11.25.08
C Change Surgical did not seek premarket approval or clearance for its IntraTemp solution warmer, which is used to control sterile fluid temperatures, before marketing or selling the device, according to an FDA warning letter.
The agency also cites the company for making changes to the device’s electrical circuitry without submitting a new 510(k). Other violations include failing to establish and maintain procedures for verifying the device design; failing to ensure that all equipment used in the manufacturing process met specified requirements; failing to conduct quality audits; and failing to ensure that all personnel are properly trained.
C Change Surgical’s CEO Patrick Kammer said the company has addressed the issues and has requested a follow-up FDA inspection.
The warning letter is available at: http://www.fda.gov/foi/warning_letters/s6989c.htm.
SOURCE: FDA NEWS
The agency also cites the company for making changes to the device’s electrical circuitry without submitting a new 510(k). Other violations include failing to establish and maintain procedures for verifying the device design; failing to ensure that all equipment used in the manufacturing process met specified requirements; failing to conduct quality audits; and failing to ensure that all personnel are properly trained.
C Change Surgical’s CEO Patrick Kammer said the company has addressed the issues and has requested a follow-up FDA inspection.
The warning letter is available at: http://www.fda.gov/foi/warning_letters/s6989c.htm.
SOURCE: FDA NEWS