483
Medas, Inc.FDA 483 - Medas, Inc. - July 25, 2022
Record Details
An FDA inspection of Medas Inc, a medical device repackager/relabeler in Miami, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control of storage areas, equipment calibration, and medical device reporting. These issues indicate a lack of robust quality management practices.
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ID · b5152cef-7c1e-46a9-aa39-074b7fff227a