483
Louisville APL Diagnostics, Inc.FDA 483 - Louisville APL Diagnostics, Inc. - December 19, 2022
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Record Details
Louisville APL Diagnostics, Inc., a medical device manufacturer in Texas City, TX, was inspected by the FDA from December 14-19, 2022. The inspection revealed significant deficiencies in labeling control, complaint handling procedures, and design validation documentation. These issues indicate a need for improved quality system compliance.
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ID · e86d2ccd-3994-4568-8390-04ad4fa091c0