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Weekly UpdatesTEFTEC Corp., San Antonio, TX Dallas District
The manufacturer of OmegaTrac and BetaTrac powered wheelchairs, TEFTEC was found out of compliance with regulations relating to complaint handling, CAPA and design by FDA investigator Brenda Stewart-Munoz at the conclusion of her inspection.
Stewart-Munoz wrote in the 483 that the firm's management "did not ensure adequate staffing to handle complaints, proper management and employee training on the Quality System Regulations, and make quality system procedures available to employees at their designated work locations." She noted that 1,277 of 1,315 incoming customer calls had not been reviewed and evaluated to determine if they were valid complaints and if investigation was necessary. The employee who answered the service and complaint calls had not been properly trained to differentiate between a service call and a complaint, the FDAer stated. Moreover, this technician was not aware of what a Medical Device Report (MDR) or a Corrective Action Report (CAR) was.
The investigator further wrote that the company's complaint handling procedure itself did not clearly define the difference between a service call and a complaint, and gave examples of similar complaints that were classified differently. She also observed that the firm's employees exchanged product information with users via the company's website discussion board, and advised customers to send in products for repair or upgrade. However, the complaint handling procedure did not allow for addressing complaints in this manner, nor did TEFTEC "conduct follow-ups to the users involved to determine whether these user reports are considered valid complaints or not."
TEFTEC's complaint procedure "states that if a customer call is considered a complaint, the database has been designed to assign a CAR. The respondent has 30 days to evaluate the CAR and issue a response." However, out of 40 CARs that the FDAer reviewed, 38 had not been handled in a timely and uniform manner, Stewart-Munoz stated in the report of the Feb. 6-March 10, 2006, inspection.
The investigator also faulted TEFTEC for not reviewing complaints to determine if investigation is necessary. "The CAR has a section for description of nonconformance and for cause of nonconformance. Both of these sections are vague in the description of the nature and details of the complaint." In addition, she wrote, "Of 1,277 customer calls reviewed, there were approximately 233 types of service calls that included potential complaints based on the information received from the customer." The CARs also included "incomplete and inadequate documentation," the inspector stated, citing reports that showed no documentation of investigations, causes of nonconformance or CAPA.
The company's failure to properly differentiate between service calls and complaints also led to problems in properly identifying MDRs, the investigator wrote. TEFTEC wrote that of the 1,277 calls there were no reportable MDRs. However, the FDAer noted seven calls that referenced accidents or defects in performance that could result in accident and injury.
TEFTEC also failed to establish, document and implement procedures for validating device design. Stewart-Munoz noted that after numerous complaints about the joystick on the company's powered wheelchairs, the contract manufacturer modified the joystick at TEFTEC's request. However, the company did not have a test procedure to validate the modification.
Further, when the contract manufacturer provided a prototype of the new joystick, the FDA investigator wrote, "Reportedly, the joystick was tested on a few chairs located at the firm and sent out to a customer to test." The customer suggested certain modifications, which the manufacturer made. The joystick went into production in June 2005; however, the inspector wrote, "There is no documentation of the testing conducted at the firm or by the customer."
Products returned due to nonconformance are returned to the contract manufacturer for rework, the 483 reported. However, "it is not always clear as to what rework was performed on the product, as the documentation is in French. In-house testing and/or evaluation of the reworked product is not performed and there is no established procedure for the evaluation of the contract manufacturer's rework documentation."
TEFTEC "has not established a design plan to predefine and document design and development activities, including the responsibility for implementation, interfaces with different groups or activities that provide the design inputs," Stewart-Munoz wrote, after reviewing the company's reported process for redesigning the joystick following complaints.
In its response to FDA's warning letter, TEFTEC wrote that it regarded "the observations listed to be very serious and we are taking additional and appropriate corrective action to resolve all issues." The firm hired a third-party consultant to help it make "improvements to our overall quality system."
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