Company:General Medical Co.
Product: “Drionic Long-term Antiperspirant for Hands & Feet,” “Drionic Long-term Antiperspirant for Underarm Treatment” and “Drionic Special Applications Device for Amputee, Groin and Buttocks”
Date: 9/8/04

Your firm failed to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example, software validation has not been performed for changes .you made to the “CHECKSUM” system program. The “CHECKSUM” is used to measure the current output level for the final testing of the devices. [FDA 483, Item #9]

FDA District: Los Angeles District Office