Warning Letter – Sooil Development Co. Ltd.

Company: Sooil Development Co. Ltd.
Product:Insulin infusion pump
Date: 11/24/04

Failure to document the results of the design validation in the design history file, as required by 21 CFR 820.30(g). For example, the documentation of the bolus and basal infusion testing involving the dispensing software was incomplete. Additionally, as part of your software validation, the report titled _____ did not identify the lot numbers of the motor and gear assembly used, or the other components used in the device, such as the MCU, PCB, and LCD.

Issuer: Center for Devices and Radiological Health (CDRH)

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