Company: Positron Corp
Product: “POSICAM HZ,” “POSICAM HZL,” “mPower PET” and other Positron Emission Tomography diagnostic scanners
Date: 4/26/04
The above-referenced service reports indicated that an upgrade was needed. There are no records attached or referenced in these service reports or clear descriptions to explain if the upgrade was due to a hardware design problem, a software design problem or other recurring quality problems.
You terminated an employee who handled your firm’s customer complaint handling but failed to hire new employees or reassign existing employees to maintain your firm’s complaint files. An electronic customer service database was created to document customer complaints, but it was never implemented [FDA-483 Item 6].
An electronic customer service database was not implemented to document and evaluate customer complaints as required by your firm’s Complaint Handling Procedure (P.O.S. 4.14.03). This deviation was not detected by either management reviews or internal audits.
Failure to maintain complaint files for receiving, reviewing, and evaluating complaints by a formally designated unit [21 CFR 820.198(a)] [FDA-483 Item 61, a similar deviation from the previous inspection in 11/2001. For example, one of your firm’s employees created a customer service database in order to document all complaints electronically, however, your firm never implemented this database.
Failure to calibrate measuring and test equipment, including mechanical, automated, or electronic inspection and test equipment, to ensure that they are capable of producing valid results [21 CFR 820.72(a)] [FDA-483 Item 9]. For example, all the equipment listed in your firm’s Master Calibration List had not been calibrated by their due date in 2004. Your firm stated to our investigator that since your firm was not manufacturing at the time of the inspection, your firm was not required to calibrate the listed measuring equipment. Your firm’s rationale is not acceptable since these measuring equipment can be used to verify the results produced during either in-house repairs of electronic/assembly components, design changes or when your firm begins to manufacture new device units.
FDA District: Dallas District Office
