483
Red Medical Solutions, Inc.Red Medical Solutions, Inc. – FDA 483, Mar 22, 2023
Record Details
An FDA inspection of Red Medical Solutions, Inc., a medical device importer and exporter in Patchogue, NY, revealed significant deficiencies in their quality system. The firm failed to establish procedures for receiving, reviewing, and evaluating customer complaints. Additionally, the company lacked established procedures for corrective and preventive actions, particularly concerning investigations into non-conforming devices.
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ID · e0d2809a-8e81-4c4e-99ca-5fd2c76f9bc9
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