White Paper: Key Components of a Compliant

Product Complaint Handling System

According to FDA’s 2015 enforcement statistics, Medical Device companies’

Product Complaint Handling system (21 CFR 820.198: Complaint Files) is the
second most cited 483 with 294 Turbo EIR observations, representing 3% of all EIR
observations. It is expected that FDA will continue to focus on the Product
Complaint Handling system, as well as other post market surveillance systems, with
the use of the Medical Device Single Audit Program (MDSAP) and implementation
of FDA’s Post Market Surveillance Program1.

Review of 2015 and 2016 FDA 483’s and Warning Letters related to Product
Complaint Handling system indicates that a FDA 483 is most frequently issued as a
result of the (1) lack of or inadequate procedures; (2) failure to follow established
procedures; or (3) lack of documented evidence (good documentation and data
integrity).

A robust and FDA compliant Product Complaint Handling system requires written
procedures for complaint handling and record keeping that meet the requirements
of 21 CFR 820.198, integration of the system in the overall Quality Management
System (QMS), trained personnel for effective implementation and periodic
monitoring.

FDA Enforcement Statistics for Medical Devices:

FDA’s Office of Regulatory Affairs (ORA) maintains spreadsheets that summarize

and trend 483’s issued through the FDA’s automated Turbo Establishment
Inspection Report (EIR) Form 483 reporting system. Not all FDA 483’s are

1
The Postmarket Surveillance initiative was started in June 2014 and expected to be completed by
the end of 2017. The initiative includes increased funding to FDA to improve post market
surveillance, Senate review of the effectiveness of FDA’s postmarket surveillance, implementation of
priority guidance documents related to postmarket surveillance and the National Medical Device
Evaluation System (NMDES). NMDES is also part of CDRH’s strategic goals for 2016/2017as stated
in their published document.

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 generated in Turbo EIR as some 483’s are manually prepared and not available to
include in the data.

The 483 summary and trend reports are issued by ORA by fiscal year and break
down inspectional observations by division or program areas, inspectional
observations by area of regulation and frequency of citation within a 483
(www.fda.gov\ICEC).

What is a 483?

The U.S. Food and Drug Administration (FDA) are authorized to perform
inspections under the Federal Food, Drug and Cosmetic Act (FDCA).

Form FDA 483, "Inspectional Observations", is a form used by the FDA to list the
conditions or practices observed during the inspection that are considered to be in
violation of the FDCA. The FDA Form 483 is also referred to as Form 483 or simply
483.

What is a Product Complaint?

In the context of FDA regulations for Medical Devices, a product complaint is

defined as any written, electronic, or oral communication that provides notification
that a product in commercial distribution may be in violation of FDA regulations,
does not meet standards for identity, quality, durability, reliability, safety,
effectiveness, or performance, may have caused an illness, injury or death or may
have caused any other problem not covered by the aforementioned.

A product complaint can be made directly to a manufacturer or indirectly through

knowledge from another source to the manufacturer.

What are the Key Components of a Compliant Product Complaint Handling

System?

The Product Complaint Handling system is part of the overall Quality Management
System (QMS) and is used in conjunction with postmarket product surveillance and
corrective and preventive action programs to monitor a device during real life use,

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 to ensure continued product quality and to allow continuous development and
optimization of a product design.

The Product Complaint Handing system defined in 21 CFR 820.198 (Complaint

Files) requires procedures and processes for receiving, evaluating, investigating,
remediating, documenting and reporting, record keeping and trending of product
specific complaints. Procedures and processes must ensure timely and systematic
processing by a formally designated unit by trained and qualified personnel.

1. Receiving:
o All complaints must be documented, regardless if received by oral or
written communication.
o Record the receipt in complaint logs or files. Include initial information
surrounding the complaint, such as the date complaint was received,
the device identification & control number, the complainant
information and the nature and details of the complaint.
2. Evaluating:
o Evaluate the complaint for required reporting under 21 CFR 803 for
serious or life threatening events (Medical Device Report or MDR).
o If the complaint triggers a MDR, clearly identify the complaint file or
maintain separately from other complaint files.
o Evaluate the complaint to determine if additional investigation is
necessary, as in the case of a possible failure of a device, labeling, or
packaging to meet any of its specifications. An investigation is not
necessary if an investigation has already been performed for a similar
complaint.
o If an investigation is not required, document the name of the individual
responsible for the decision and the justification.
3. Investigating:
o Investigate the complaint by systematic techniques, such as Failure
Mode Effect Analysis (FMEA), the 5 Whys and Fishbone Cause &
Effect Diagrams.
4. Remediating:
o Implement appropriate corrections, corrective actions and preventive
actions.

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 5. Documenting:
o Document details in the complaint file:
o Date complaint was received
o Device identification & control number
o Complainant info
o Nature & details of the complaint
o Dates and results of the investigation
o Any CAPA
o Any reply to the complainant
o Record details of the MDR assessment and any communication with
FDA.
o Include information as to whether the device failed to meets its
specifications, whether it was being used for treatment or diagnosis
and the relationship, if any, of the device to the reported incident or
event.
o Document any reply to the complainant.
6. Recordkeeping:
o Maintain complaint files for a period equal to the expected life of the
device, but in no case less than two years from the date the releases
for commercial distribution
o Make sure all records are accessible, regardless if the formally
designated complaint unit is located at a site separate from the
manufacturing establishment.
7. Trending:
o Monitor complaints for trends as part of the QMS system.

With consideration of these key components for procedures and processes,

effective implementation and monitoring, a compliant Product Complaint
Handling system can be implemented to avoid potential enforcement actions.

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 AOUT THE AUTHOR: Ms. Kimberly Johnson is a certified A.S.Q Quality Auditor, is currently obtaining her Master’s Degree in Quality and
Regulatory Affairs from Temple University and has a B.S. in Chemistry from the State University of New York at Oswego. Ms. Johnson is
a seasoned professional with over 25 years of experience in the pharmaceutical and medical device industries working in GLP, GMP, ISO
and DEA regulatory environments. She is skilled in the development, implementation, maintenance and continuous improvement of
Regulatory Affairs from Temple University and has a B.S. in Chemistry from the State University of New York at Oswego. Ms. Johnson is
a seasoned professional with over 25 years of experience in the pharmaceutical and medical device industries working in GLP, GMP, ISO
and DEA regulatory environments. She is skilled in the development, implementation, maintenance and continuous improvement of
various Quality Management Systems that include Audits & Inspections, Document Management, Change Management, Risk
Management, Corrective and Preventive Action and Effectiveness programs, Deviations and Investigations, Complaint and MDR
Handling, Supplier Qualification, Data Integrity and Quality System Management Metrics and Trending. Ms. Johnson has held positions
in Analytical Research, Regulatory Affairs and Quality Assurance within multinational and virtual companies, such as Bristol Myers
Squibb, Wyeth-Ayerst, Purdue Pharma, Watson and Pharmaceutics International, Inc.

© PathWise Inc., 2016

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