MAPLE GROVE, Minn. -- SterilMed announces that it has successfully concluded its third biannual Food and Drug Administration (FDA) audit after a routine on-site inspection in August. After three days of combing through documentation, the FDA auditor issued no observations, corrective actions or citations. The comprehensive audits involved all SterilMed systems, including elements of the complaint and CAPA system, design history files, production and process controls, as well as overall company management. FDA inspectors evaluated internal documentation supporting SterilMed quality systems and the way it does business, in addition to spending time on the production floor to observe all device reprocessing. As a third-party reprocessor of single-use medical devices, SterilMed complies with the same standards as leading medical device manufacturers.
Brian Sullivan, SterilMeds CEO and president, commented, These exemplary results are quite rare in the medical device industry. Medical device manufacturers, as a heavily regulated industry, are audited by the FDA on no less than a biannual basis. For these types of unannounced audits, FDA auditors often issue formal observations, or even worse, a warning letter requiring the manufacturer to address any deficiencies within a specified time period. These findings support the ethical and quality manner that SterilMed conducts business and its compliance with FDA regulations.
SterilMed is a leading third-party reprocessor of single-use medical devices, providing the highest quality service to hospitals and other facilities nationwide.