483
HUCK MEDICAL TECHNOLOGIES, Inc.FDA 483 - HUCK MEDICAL TECHNOLOGIES, Inc. - April 17, 2025
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Record Details
An FDA inspection of HUCK MEDICAL TECHNOLOGIES, Inc. in Jacksonville, TX, a class I device manufacturer, revealed significant deficiencies in their quality system. The firm failed to document management reviews, perform quality audits, and maintain personnel training records. These findings indicate a lack of adherence to established procedures and regulatory expectations for device manufacturing.
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