483
Invotec International Inc.FDA 483 - Invotec International Inc. - November 04, 2021
Record Details
An FDA Form 483 was issued to Invotec International Inc. in Jacksonville, FL, following an inspection of their medical device manufacturing facility. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning complaint investigations, incoming product acceptance procedures, and supplier management. These issues indicate a lack of adequate controls to ensure device quality and compliance with regulatory requirements.
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