483
Tecomet, Inc.Tecomet, Inc. – FDA 483, Nov 15, 2019
Record Details
An FDA inspection of Tecomet, Inc. in Boulder, CO, a contract medical device manufacturer, revealed significant quality system deficiencies. The firm failed to adequately validate processes and software, and lacked proper procedures for corrective and preventive actions, complaint handling, nonconforming product control, acceptance activities, and quality audits. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.
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ID · 24817455-a38f-41ba-af9a-cdb9ec0c99eb
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