Procedural lapses yield 9-item 483 for Lynn Medical Instruments.(MEDICAL DEVICES)

Lynn Medical Instrument Company, Wixom, MI Detroit District

Due to its failure to establish a variety of quality procedures, Lynn Medical Instrument Co. received a nine-item 483 following an inspection Feb. 6-21, 2008, by FDA investigators Anatasia Piliafas-Brown and Danielle Mills.

The company's procedure for conducting quality audits was incomplete because it did not provide instructions on how such audits should be conducted to assure that Lynn's quality system was in compliance with FDA quality regulations, the FDAers wrote. In addition, they found no objective evidence available for review to demonstrate that the company had conducted an internal quality audit since its last FDA inspection in April 2005.

Piliafas-Brown and Mills also found no objective evidence "to demonstrate that management with executive responsibility has reviewed the suitability and effectiveness of your quality system. In addition, your firm has not established procedures which provide instructions for conducting management reviews." Further, management with executive responsibility had not appointed in writing a management representative to ensure quality system requirements were met and to report on the performance of the firm's quality system, the inspectors added.

Lynn Medical Instruments, the specification developer of the Accusensor Carbocone ECG electrode, had not established procedures to identify, document, validate, verify, review and approve design changes prior to their implementation, the inspectors observed, nor had the firm established any incoming acceptance or rejection procedures for this device.

The company had no written agreement with the contract manufacturer for the electrode under which the manufacturer agreed to notify Lynn of changes in the product or service so that Lynn could "determine whether the changes may affect the quality of the finished device," the 483 reported.

The investigators stated that the company's CAPA procedures were incomplete because it had not established requirements for analyzing sources of quality data "to identify existing and potential causes of nonconforming product or other quality problems." Lynn also had no requirements for investigating the cause of non-conformities relating to the product, processes or quality system; identifying actions needed to correct and prevent the recurrence of such problems; verifying and validating CAPA to ensure that it is effective; implementing and recording changes in procedures and methods needed to correct quality problems; and submitting relevant information on quality issues and CAPA for management review.

Lynn's complaint handling procedure was deemed incomplete by the FDAers because it did not provide instructions for receiving, reviewing and evaluating complaints by a formally designated unit. The procedure also did not ensure that all complaints were handled in a uniform and timely manner; that oral complaints were documented on receipt; and that complaints were evaluated for MDR reportability.

Written MDR procedures had not been developed, the 483 reported. The company's internal systems did not provide for timely and effective identification, communication and evaluation of events that might be subject to MDR requirements; did not include a standardized review process or procedure for determining when an event meets the criteria for reporting to FDA; and did not ensure timely transmission of MDR reports to FDA and manufacturers.

Lynn Medical Instrument Co., Wixom, MI, 2/6-21/08, Doc.110128M, $4.50 plus retrieval

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