FDA 483 - Morgan Newton Comp. - May 12, 2023

Morgan Newton Comp. in Plano, TX, a contract manufacturer, received a Form FDA 483 with two observations. The inspection revealed deficiencies in the documentation of rework and reevaluation activities, specifically regarding the determination of adverse effects on products and the validation of rework. Additionally, the firm failed to adequately maintain device history records, as product acceptance and rejection statuses were not clearly identified, and testing results for replacement products were missing.