483
Richmond Diagnostics, Inc.FDA 483 - Richmond Diagnostics, Inc. - July 25, 2025
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An FDA inspection of Richmond Diagnostics, Inc. in North Brunswick, NJ, revealed significant deficiencies in their quality system. Observations included failures to ensure device history records demonstrate manufacturing in accordance with master records, inadequate procedures for corrective and preventive actions, and a lack of established procedures to control nonconforming product.
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ID · 98727569-067e-4125-ad78-afeff7e38ad2