Company: Ocuserv Instruments Inc.
Product: Ultrasonic Imaging Systems, Autoscan DB 3000, DB 3000C Biometric Rulers and Ophthalmic A-Scan Systems
Date: 3/2/04
During an inspection of your firm located in Jamaica, New York, conducted during the dates of January 13, 14 & 23, 2004, our investigator determined that your firm manufactures medical devices under the brand names of “Ultrasonic Imaging Systems (a/k/a) Autoscan DB 3000 & DB 3000C Biometric Rulers, Ophthalmic A-Scan Systems”. These devices are software driven and measure the axial length of the eye, anterior chamber depth, and lens thickness plus calculate the power of an intraocular lens that replaces the eye’s natural lens after cataract surgery. These are devices within the meaning of section 201 (h) of the Federal Food, Drug and Cosmetic Act (the Act).
Failure to document process validation results and activities as required by 21 CFR 820.75(a).
Specifically, the software transfer process using your firm’s ChipMaster 3000 (V.2.61) programmer has not been validated to assure that it is capable of reproducing and completely copying the master software program onto a blank …chip that will subsequently be installed into the finished device, an Ophthalmic Autoscan DB 3000C System.
Failure to establish the appropriate responsibility, authority and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform tasks as required by 21 CFR 820.20(b)(1).
Specifically, your firm’s quality system does not address responsibility and authority for the following: overseeing device production, control and maintenance of the quality system, finished device testing, device software validation, equipment calibration, incoming raw material inspections, approving and implementing corrective and preventative actions and the handling of consumer complaints.
FDA District: New York District Office
