Company: Merits Health Products Co. Ltd.
Product: Powered wheelchairs, electric scooters and oxygen concentrators
Date: 02/04/2003

Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, the FARAD Model ARC MATE 100i(B) CO2 Welding Robot has not been adequately validated to verify the various movements of the automated robotic arm using actual product, and no other evidence of process performance qualification was available.

Issuer: Center for Devices and Radiological Health (CDRH)