Company: Computerized Radiation Scanners Inc.
Product: radiation beam scanners
Date: 10/19/04
Each manufacturer shall establish procedures for quality audits and conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22. Your firm failed to conduct internal audits at sufficient regular intervals since 1999-2000 even though your internal audit procedure requires that such audits be done on an annual basis. Your audit procedures also fail to address essential criteria including: purchasing control, process validation (software validation), design control, corrective and preventive action (CAPA), and Medical Device Reporting (MDR) (FDA 483, Items #3 & 4).
Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and, shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. All results of the design validation including the identification of the design, method(s), the date, and the individual(s), performing the validation, shall be documented in the Design History File (DHF) as required by 21 CFR 820.32(g). The results of design validation including identification of the design methods, the date, and the individual performing the validation were not documented in the DHF. Your firm also failed to document risk analysis or design input associated with a software design change related to complaints dated 5/13/2004 and 11/27/2003. There was no documentation covering the change of a resistor and a design change to the electrometer to assure the changes did not adversely affect the performance of the finished device (FDA 483, Items #5 & 6).
FDA District: Florida District Office
