MEDISISS Successfully Completes FDA Inspection
June 2, 2009
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MEDISISS SUCCESSFULLY COMPLETES FDA INSPECTION
Redmond, OR: MEDISISS, the reprocessing industry leader in the Ambulatory Surgery Center marketplace, is pleased to announce that the company has once again successfully completed an FDA inspection (known as a "Quality System Inspection Technique" or QSIT).
During such an inspection, all facets of a reprocessor’s business operation, quality systems and sub-systems are reviewable by the FDA. Potential areas which may be targeted for inspection include 510(k) clearances,Design Control Systems, Production & Process Controls (i.e. Cleaning, Packaging, Labeling & Sterilization), Equipment Controls, Raw Material Controls, Functionality & Inspection Controls, Corrective And Preventative Action Programs (CAPA’s), Non Conforming Reports, Internal Audits, Management Reviews and Customer Complaints.
In all aspects of the FDA’s review, MEDISISS was found to be in compliance. No "Observations" or "Deficiencies" (as referenced by the FDA’s Form 483) were noted. Having been deemed as compliant with the regulations and areas inspected, MEDISISS remains in good standing with the FDA.
According to MEDISISS CEO, Jason Wandersee, the stellar achievement is in line with the company’s Mission Statement: "As is evidenced by the excellent results of this inspection, our team remains committed to providing the highest level of quality to ensure Patient Safety, Surgeon Satisfaction and FDA Compliance. We are very proud of the efforts of every employee who contributed to this extremely successful endeavor."
MEDISISS, headquartered in Redmond, Oregon, is a registered Third-Party Medical Device Reprocessor of Single-Use Devices (SUDs) with offices and distribution channels established throughout the country.