Medical products and outsourcing services firm Colorado MedTech today announced its receipt of a warning letter from the U.S. Food and Drug Administration. The letter states that there are certain areas in which the company’s Longmont, CO, contract medical device manufacturing facility is not in compliance with the FDA’s quality system regulation (QSR), according to Colorado MedTech.
The Boulder, CO-based firm said it has been working to improve its QSR compliance and is addressing the FDA's concerns. To that end it has presented a correction action plan to the FDA and a detailed response. The firm said it has also retained industry consultants to ensure that its quality system meets or exceeds all requirements.
The company has begun to implement new procedures and training, and is working with its vendors to ensure that their components meet Colorado MedTech’s improved quality system. The firm hopes to address all of the deficiencies by this spring, according to president and CEO Stephen Onody.
By AuntMinnie.com staff writersJanuary 31, 2001
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Colorado MedTech gets new CEO, June 26, 2000
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