Norman Noble Inc – FDA 483, Mar 24, 2023

Norman Noble Inc, a medical device manufacturer in Highland Heights, OH, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in process validation, including inadequate revalidation of equipment and cleanrooms, and missing documentation. Further issues were identified in the establishment and execution of corrective and preventive action procedures, supplier control, and the management of nonconforming products.