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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Page 4

 

Guide to Inspections of Medical Device Manufacturers 

 

 December 1997 

 

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 1. Complaint Handling System - 21 CFR 820.198 

This should be the beginning point of every inspection to determine whether the firm has received complaints of possible (or potentially) defective devices. The QS/GMP regulation requires all complaints be reviewed, evaluated and maintained by a formally designated unit. This unit could be one appropriately trained individual, or a department which is staffed with appropriately trained individuals. This unit must decide whether an investigation of the complaint needs to be performed. 

Under the QS/GMP there continues to be no requirement that all complaints be maintained in one file. However, firms are now required to have written procedures for processing complaints. To assess the adequacy of the written complaint handling procedures, only complaints received after June 1, 1997 should be reviewed. However, the review of complaints to determine which devices the inspection should be focused on should not be limited only to those complaints received after June 1, 1997. The complaint file(s) must contain all complaints including those open or still under investigation. 

Typically, manufacturers will keep complaints in a customer file, product returns/credit file, service file, warranty file, medical file, or legal file. The inspection should ascertain what files are maintained that meet the definition of a complaint (21 CFR 820.198). By placing complaints in different files, manufacturers may not have noted instances of repeated component/device failures with a common cause. Ask the firm if it trends or performs other analyses of complaints. If no trending or problem identification is done, then the inspection should begin with a trending of the complaints. 

NOTE: The actual complaints may provide leads in identifying product defects. Deficiencies in complaint handling practices may result in lost complaint data essential to identifying product defects, and possibly quality system problems, which have not been adequately corrected by the firm. Possible corrective actions may include recall, and/or change in the design of the device, and/or change in the manufacturing process or quality system. 

Review and analyze the complaints to identify existing and/or potential causes of nonconforming product or other quality problems by grouping similar products, failure modes, and failure site (use, location) for possible user or environmental related problems. 

Potential environmental factors that could contribute to the failure of a device include the area of the country, weather, use factors, electromagnetic interference, vibration, shock, etc. 

Determine if the firm has performed sufficient complaint investigation, or to the extent possible, to confirm the reported failure mode. 

Determine the identity and qualifications of those who review complaints. Ascertain the basis for determining significance of complaints and how follow-up is conducted. Determine if oral or telephone complaints are documented. 

Some firms file complaints under other names, such as "Trade Inquiries," "Technical Assistance," "Customer Contacts," "Service Requests" etc., while others make a distinction between physical/mechanical and medical complaints. Make sure all complaints are adequately covered and reported. 

When a manufacturer claims to have received no complaints, determine if provisions have been made for the review and investigation of complaints when received. Determine who has been assigned the responsibility to evaluate them when and if they occur. 

 

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