Company: Inceptio Medical Technologies LC
Product: “Punctsure Vascular Access Imaging Procedure Kits” and other ultrasonic vascular imaging systems and sterile accesories
Date: 7/14/04

Failure to validate a process for which results cannot be fully verified by subsequent inspection or test, [21 CFR 820.75(a)]. Your sterilization process validation for the Punctsure Vascular Access Imaging Procedure Kits is inadequate in that it was performed on product manufactured for you by another firm. You now manufacture these device accessory kits _____ There is no documentation to support the contention that the bioburden, packaging integrity and sealing parameters of your currently manufactured product is the same as that upon which the validation was conducted. In addition, the assembly and test processes in your Punctsure II Electronic Assembly & Test Procedure have not been validated.

Failure to establish and maintain procedures for the identification, documentation, validation, review, and approval of design changes before their implementation, [21 CFR 820.30(i)]. Design changes made to your Punctsure Ultrasonic Vascular Imaging System and its software in _____ were not validated, and approval of the design changes were not documented.

Failure to establish and maintain procedures to control documents as required by your Document Control Policy, your Engineering Change Policy, and [21 CFR 820.40]. Our investigator observed that three versions of the Product Service Form had been used in taking product complaints; however, none of them matched the “master document” located on your firm’s computer network.

FDA District: Denver District Office