Medical devices and outsourcing firm Colorado MedTech of Boulder, CO, has received a letter from the Food and Drug Administration resolving the agency's warning letter from earlier this year. In the letter, the FDA had identified issues relating to the firm's Longmont, CO, medical device manufacturing facility.
Colorado MedTech said that the new letter clears the way for FDA review of all pending premarket submissions and FDA export certificates for medical devices manufactured for the company's clients at the Longmont facility. The vendor said it expects to resume medical device manufacturing in the next two to three weeks.
By AuntMinnie.com staff writersOctober 15, 2001
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Colorado MedTech reports progress with FDA, September 17, 2001
Colorado MedTech tagged with Q4, 2001 loss, August 21, 2001
Colorado MedTech inks supplier agreement, July 17, 2001
Colorado MedTech slips into the red in Q3, May 8, 2001
Colorado MedTech gets FDA warning letter, January 31, 2001
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