Support for US FDA Quality System
Regulation Inspections 21 CFR 820
Be prepared for your FDA Inspection through UL’s package of
services delivered by staff experienced in FDA inspections.
The FDA is increasing the number of inspections for Medical Device manufacturers
overall, but is especially focused on increasing the number of inspections of
manufacturers outside of the US. The FDA has hired hundreds of inspectors since
2010, and is making an effort to perform more inspections, making it more likely
that one of your sites will be subject to inspection. There have been a number of
companies that have had significant FDA enforcement actions, including 483s,
Warning Letters, recalls and consent decrees, several of them very public. On top
of that, FDA requirements and interpretations are constantly changing; one of the
reasons FDA refers to the program as current Good Manufacturing Practice (cGMP).
It may be prudent to have
an FDA Mock or “Practice”
audit conducted.
An FDA QSR Inspection is Different than an
ISO 13485 Assessment
On paper, the US regulation, 21 CFR 820 and ISO 13485 have many similarities
with respect to the requirements for medical device manufacturing quality
systems. Despite these similarities, it is the interpretation and the approach of
the auditor or inspector that makes the experience of a US FDA inspection very
different than an ISO 13485 or other third party system assessment.
There are some differences between 21 CFR 820 and ISO 13485 worth noting.
The FDA goes into deep detail, usually beginning with complaints and CAPAs,
whereas an ISO audit is process-based.
One of the more notable differences is that while you have a choice in your ISO
13485 Registrar or EU Notified Body, when it comes to US inspections, you are
subject to the authority of the FDA, which has the ability to impose fines and
other enforcement actions that can substantially damage your ability to sell
devices in the US.
The FDA QSIT audit approach is focused on high level subsystems. Once an inspector
follows the trail of one major subsystem, all the underlying subsystems come out
during the review of the major subsystem. The FDA inspector can spend as much
time as needed until they are satisfied with the state of control.
US FDA Quality System Regulation Inspection Support
In contrast, the ISO 13485 approach
Notable Differences Between ISO 13485 / Notified Body Audit and FDA Inspection:
is very process-oriented. Continued
ISO 13485 / Notified Body
FDA Inspection
compliance is achieved by reviewing
Ongoing business relationship established between
Public health, paid for by public funds – Enforcement
discrete processes and clauses from
manufacturer and assessment team.
mentality
Process Inspection – with an agenda, so manufacturer
Systems inspection – no set agenda.
the standard over a three-year period,
knows which processes will be reviewed.
which generally means that sampling is
Defined time limit – Assessors rely on manufacturer for
Undefined time for onsite inspection – public funds
less inclusive. The relationship between payment to sustain business.
pay inspectors regardless of number of inspections
completed.
a manufacturer and the Registrar/
Scheduled
visit.
May be an unannounced inspection.
Notified Body is an ongoing business
No limitations on what can be audited.
Specific limitations on what records can be audited –
relationship.
No Management Review or Internal Audits.
UL Services to Support Manufacturers both Before and After the FDA Inspection
FDA Mock / Preparatory Audit:
The FDA Preparatory or “mock” or “pretend” audit is a practice
inspection conducted by UL professionals experienced in FDA
inspection that mimics the FDA inspection style and discover any
gaps in your quality system according to FDA QSR – 21 CFR 820.
Gap Assessment
If your company is only looking for an assessment of a specific
function or system, we can provide a gap assessment for that in
accordance with the FDA QSR. When reviewing the types of FDA
inspections and the FDA approach, such an assessment can be
invaluable in preventive action, particularly for non-US facilities,
which will always receive a full FDA inspection.
FDA Inspection Readiness Training
Our expert team will deliver information to your entire team so
they are better prepared for the inspection, including knowing
what to expect, how to respond and how to plan for the audit.
We will share best practices during the audit that will help
improve confidence and ease for any required responses.
Remediation
If you have found areas in your quality system that need to be
revised, we will work with your team to assess compliance with
the QSR so that your systems are in compliance.
Support During an Inspection
Our experts can accompany your team and the FDA inspector
during the inspection to address questions, identify potential
areas that need work and identify any potential problems.
T: 877.854.3577 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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US FDA Quality System Regulation Inspection Support
Other Services
• Preparatory Inspection for an FDA Pre-Approval Inspection
(PAI) – Required for a PMA submission, these inspections are
very specific to one product. Having UL conduct a practice
audit can help you understand how prepared your company is.
• Pre-Registration Inspections – If you have sites that are not
currently registered with the FDA, this inspection will help
them prepare by offering a simulated inspection focusing on
the product and utilizing QSIT methodology used by the FDA
inspectors.
Situations Where it May be Prudent to have an FDA
Mock or “Practice” Audit Conducted
• If you are planning on registering your facility or a product
with the FDA – you are eligible for an audit.
• If you have a foreign establishment.
• When you are preparing a PMA submission.
• If you haven’t been audited by the FDA recently.
• If you are a contract manufacturer, as of 2010, you must
register with the FDA.
• If the FDA has recently inspected a parent company or design
specification holder, and has concerns, there is an increased
chance they will follow those concerns to the contract
manufacturer.
Process – Items Needed to Get a Quote
UL services support
manufacturers both before
and after the FDA inspection.
Why Work with UL as a Third Party
• UL has an unmatched history of independence and application
of requirements/standards.
• UL is a trusted conformity assessment organization with a
focus on application of requirements and standards.
Advantages to Working with UL
1.The US Food and Drug Administration (FDA) has a unique
partnership with UL: a Cooperative Research and Development
Agreement (CRADA), in which UL provides the online training
that the FDA employs to train more than 36,000+ federal, state
and local investigators in the areas of quality and compliance.
2.UL has over a 115 year history of supporting public safety in
the US with a reputation for integrity and trust.
3.UL’s team includes professionals experienced in FDA
inspections and with offices around the world, you can speak
with UL’s staff in your local language and time zone.
Contact: E: Medical.Inquiry@ul.com, P: 877.854.3577
Contact your UL representative to initiate the process.
We will need some basic information, such as:
• Whether you have ever been audited by the FDA and the
results.
• What quality system registrations you have.
• Type of devices manufactured.
• Number of sites.
• Timing (when you want the services).
• Scope of services needed.
• Are you expecting to have an FDA audit.
Sources:
• Level of experience of auditor required.
FDA Enforcement Story http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/UCM129823.pdf
Once we have these items, we can prepare an estimate of
time and cost. We can share the CVs of our expert audit team
and set up a few teleconferences so you can choose the expert
with whom you are most confident.
Laska, Susan. Deputy Director Division Foreign Field Investigations FDA. “Division of Foreign Field
Investigations” http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM255116.pdf
http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf
http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM255116.pdf Susan Laska,
Deputy Field Director, FDA Foreign Inspections
T: 877.854.3577 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540
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About UL EduNeering
UL EduNeering is a business line within UL Life & Health’s Business Unit. UL is a premier
global independent safety science company that has championed progress for 120 years. Its
more than 10,000 professionals are guided by the UL mission to promote safe working and living
environments for all people.
UL EduNeering develops technology-driven solutions to help organizations mitigate risks,
improve business performance and establish qualification and training programs through a
proprietary, cloud-based platform, ComplianceWire®.
For more than 30 years, UL has served corporate and government customers in the
Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance
management approach integrates ComplianceWire, training content and advisory services,
enabling clients to align learning strategies with their quality and compliance objectives.
Since 1999, under a unique partnership with the FDA’s Office of Regulatory Affairs (ORA),
UL has provided the online training, documentation tracking and 21 CFR Part 11-validated
platform for ORA-U, the FDA’s virtual university. Additionally, UL maintains exclusive
partnerships with leading regulatory and industry trade organizations, including AdvaMed,
the Drug Information Association, the Personal Care Products Council and the Duke Clinical
Research Institute.
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Suite 301
Princeton, NJ 08540
609.627.5300
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