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The U.S. Food and Drug Administration has sent a second warning letter to Guidewire Technologies Inc. to notify the company that it is not meeting the requirements of Current Good Manufacturing Process, which is mandated by regulations for the production of medical devices.
The Salem, N.H.-based maker of medical guidewires to use in the placement of catheters had sent a letter on February 11, addressing the concerns the FDA expressed, after an inspection of the company’s facility in January. However, the FDA was not satisfied by the company’s response and sent a second letter dated February 26.
The FDA says that the company is not conducting testing after each sterilization process for sterile packed guidewires. The agency also claims that a Teflon coating process for some guidewires has not been validated by the FDA. The FDA also found that internal audits of manufacturing procedures were not being performed.
The FDA requested that the company respond within 15 days of the receipt of the letter.
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