The document provides guidance on handling FDA inspections. It discusses key points like signing the FDA Form 482 notice, having subject matter experts available to answer questions, and reviewing documentation before providing it to inspectors. It also describes the FDA's quality system inspection approach, the different inspection classifications (NAI, VAI, OAI), and what is contained in the Establishment Inspection Report provided after an inspection.

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Handling a FDA Inspections
Wednesday, June 10, 2015

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Key points for Handling of a FDA Inspection
The FDA Inspector provides notice (FDA Form 482)
of the inspection prior to the start of the actual
audit. This document has to be signed by the
highest authority in the company. At the initiation
of an audit, it may be advisable to provide the FDA
Inspector with a product overview or overview of
services provided (as in the case of a contract
laboratory).

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Key points for Handling of a FDA Inspection
This often helps the review process. Verify that
someone is recording the minutes of all meetings
with the FDA inspector. Always have a scribe as
well as a host/tour guide with the FDA Inspector.
Prior to the inspection, an internal audit of the data
submitted supporting the application should be
conducted.

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Key points for Handling of a FDA Inspection
A directed facility audit should be conducted by
trained auditors who will mimic what the FDA will
do during the PAI. This can help the company
identify any deficiencies and allow time to take
proper corrective actions. Train personnel on how
to communicate with the FDA before they arrive.

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Run It – Don’t Let It Run You
Here are tips for Handling a FDA Inspection the
right way:
Route all requested documents through a “war
room”. Provide information promptly, but review the
data prior to giving it to the FDA Inspector. Keep
separate copies of any documentation given to the
inspectors. Do not allow the FDA in your “war
room”. Have Subject Matter Experts (SME) available
to answer questions posed by the FDA Inspector.

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Run It – Don’t Let It Run You
Here are tips for Handling a FDA Inspection the
right way:
When possible, prepare the SME with likely
questions prior to the conversation between the SME
and the FDA Inspector. Ensure you understand the
question; if necessary, ask for clarification before
answering. If process validation has begun or has
been accomplished, data is likely to be reviewed
during the PAI.

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Run It – Don’t Let It Run You
Here are tips for Handling a FDA Inspection the
right way:
The proposed manufacturing process filed in the
chemistry, manufacturing, and controls section
(CMC) of the NDA/ANDA will be reviewed. Generally,
PAIs are combined with routine GMP inspections if
the facility had no GMP inspection during previous
two years.

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Run It – Don’t Let It Run You
Here are tips for Handling a FDA Inspection the
right way:
A review of all corrective actions taken by the
company resulting from the FDA’s last inspection
may be reviewed by the inspectors. Samples of the
product will be taken by the FDA Inspector and
tested in the FDA laboratory to ensure that they
meet appropriate standards.

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Run It – Don’t Let It Run You
Here are tips for Handling a FDA Inspection the
right way:
If there is a compendial method, often the sample will
be tested against it. A receipt should be given by the
inspector for any samples taken by the FDA. Form 484
is used for this purpose. Collect duplicate samples and
have analysed independent of the FDA analyses.
Continually seek FDA’s input during the audit.

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Run It – Don’t Let It Run You
Here are tips for Handling a FDA Inspection the
right way:
This gives you a chance to make corrections or
clarify misunderstandings. When handling a FDA
inspection and dealing with a FDA representative,
demonstrate knowledge of and confidence in your
quality system. Do not respond arrogantly or
defiantly.

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IMPORTANT FDA INSPECTION NOTE
When handling a FDA inspection, it is good to know
that by law the FDA cannot inspect the following:
sales data, financial data, personnel files (other
than individual qualifications), pricing data, and/or
records of a personal nature (employee evaluations,
addresses, social security numbers, and/or pay
records).

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IMPORTANT FDA INSPECTION NOTE
If these items are requested, it may be an
indication that the inspector doesn’t know or is
testing your knowledge. It could also indicate the
beginning of serious regulatory proceedings by the
government. It is suggested that notice of these
requests be forwarded to legal counsel immediately.

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The FDA’s Quality System Inspection Approach
The FDA utilizes a Quality System Inspection
Technique (QSIT) when performing inspections. This
means that the FDA looks at specific systems and
determines if deficiencies exist within that system.
The key systems are Quality, Facilities and Equipment,
Material Controls, Production, Packaging and
Labelling, and Laboratory Controls.

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The FDA’s Quality System Inspection Approach
Evidence to support a significant and/or trend of
deficiencies within an examined system could
demonstrate failure of that system and may result in
the FDA considering issuance of a Warning Letter or
other regulatory action.

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FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR)
If regulatory non-compliance observed during FDA
inspection, the FDA inspector issues “Form 483”
(Notice of Inspectional Observations) to the facility.
The contents of the 483 comprise inspectional
observations but do not represent a final Agency
determination regarding compliance.

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FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR)
The company which receives a 483 should respond to
the FDA addressing each item within 15 working days.
A response is not compulsory but a good response can
help the company avoid receiving a warning letter, or
stronger enforcement actions including withholding of
product approval or even a plant shutdown.

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FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR)
FDA provides initial classification of the inspection
based on the observations noted during the inspection,
the investigator’s report, and FDA District Office
supervisory personnel review. With the exception of
instances where procedures indicate that the relevant
product centre has the right of final classification,

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FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR)
the final classification of the inspection is made by the
FDA District Office. An inspection classification reflects
the compliance status of the establishment at the time
of the inspection, based on the observations
documented. The conclusions of the inspection are
reported as Official Action Indicated (OAI), Voluntary
Action Indicated (VAI), or No Action Indicated (NAI).

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FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR):
An OAI inspection classification occurs when
significant objectionable conditions or practices were
found and regulatory action is warranted to address
the establishment's lack of compliance with statute(s)
or regulation(s).

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A VAI inspection classification occurs when
objectionable conditions or practices were found that
do not meet the threshold of regulatory significance.
Inspections classified with VAI violations are typically
more technical violations of the FDCA (The United
States Federal Food, Drug, and Cosmetic Act).
FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR):

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An NAI inspection classification occurs when no
objectionable conditions or practices were found
during the inspection or the significance of the
documented objectionable conditions found does not
justify further actions.
FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR):

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If no enforcement action is contemplated, or after
enforcement action is concluded, FDA provides
inspected establishments with a final inspection
report, called an Establishment Inspection Report
(EIR), which includes:
Brief history of prior inspectional findings, including
FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR):

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any action taken by FDA or corrective action taken by
the firm in response to a previous inspection The
investigator’s narrative report Any refusals, voluntary
corrections, or promises made by the firm’s
management Copies of forms the FDA issued to the
firm during the inspection, including the FDA Form
483.
FDA INSPECTION CLASSIFICATION - (NAI, VAI, OAI) &
ESTABLISHMENT INSPECTON REPORT (EIR):

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Thank you very much your valuable time!