Company:Serv-A-Pure Co.
Product: Water purification systems for hemodialysis
Date: 10/10/2002
Design Control and Design Inputs and Outputs. Your response to FDA-483 observation # 4 addresses the specific observation that the records were not signed and dated. We are concerned that the records referred to in this observation are maintained on a computer system, and your response states in Section 3.3, “All critical design records and documents are dated and signed by an engineer on staff.” You need to establish and maintain a system of hard copy design records, such as required by the Design History File element of the Design Control regulation. These signed and dated documents must be considered the official design records. Continuing our review of your response to #4, you referenced the expanded sections 3.3 through 3.6 of your quality manual, therefore we have also reviewed that material. Section 3.6, Quality Engineering Design Practices, appears to be your attempt to address the Design Control elements required by 21 CFR 820.30, but you have not included all the elements listed in that regulation, and you have modified the order in which they are listed. We believe you should review the Design Control regulation, and we also suggest you review Chapter 3 of the FDA publication manual recommended above.
FDA District: Detroit District Office
