Devices & Diagnostics

FDA sends warning letter to Compass International Innovations

UPDATE BELOW: The U.S. Food and Drug Administration sent a warning letter to Compass International Innovations Inc., a manufacturer of stereotactic position systems and CT stereotactic adaptation systems, in late May. Compass International is based in Rochester, Minnesota and in addition to making these image-guided surgical systems, it sells biopsy needles and surgical arms among […]

UPDATE BELOW:

The U.S. Food and Drug Administration sent a warning letter to Compass International Innovations Inc., a manufacturer of stereotactic position systems and CT stereotactic adaptation systems, in late May. Compass International is based in Rochester, Minnesota and in addition to making these image-guided surgical systems, it sells biopsy needles and surgical arms among other products.

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The letter charges the company with four violations including:

  • failure to establish and maintain procedures for software validation related to those stereotactic systems
  • failure to properly identify and process customer complaints
  • failure to conduct quality audits to assure that the system complies with the established quality system requirements

The warning letter also notes that so far, Compass has not provided enough information for the FDA to judge whether the company has taken the necessary corrective action. Compass had 15 days since it received the letter dated May 23 to respond.

Jon Rousu, Compass International’s president, wasn’t available for comment.

UPDATE – In a phone interview Thursday, Rousu said that the company has already responded to the warning letter and has corrected three of the four violations. The business hasn’t been affected by the warning letter so far, he said.