Transcript Document

Handling
Regulatory
Inspections
Denise Webster
Fresh & Easy
April 3, 2014
• Purpose is not to give you legal advice but to give
you first hand experience and best practices in
preparing for an FDA or Health Department audit
• Why is this important?
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Inspections are increasing (e.g. high-risk sites)
Records access is broader and more complex
Fees if a re-inspection is required
Legal & Reputation risk to your company and brand - if you don’t
get it right!
• Do you have a plan?
Likelihood of Inspection
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New Facility
New Process
Change of Ownership
High-Risk (HR) vs. Non-High-Risk (NHR)
Customer Complaints
Findings (e.g. positive test results)
Recall investigation
FDA Defines High Risk
Criterion 1. Frequency of outbreaks and occurrence
of illnesses
Criterion 2. Severity of illness, taking into
account illness duration, hospitalization
and mortality
Criterion 3. Likelihood of contamination
Criterion 4. Growth potential/shelf life
Criterion 5. Manufacturing process
contamination probability/intervention
Criterion 6. Consumption
Criterion 7. Economic impact
Preparation for Inspection
• Guide to Regulatory Inspections - Review the FDA’s
IOM – Chapter 5: Establishment Inspections and
State Health Department regulations
• Have a written detailed plan
o Basic Company Information, Policies & Procedures
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Train against the plan
Don’t forget to train the receptionist
Have emergency contacts at the ready
Test the plan - annually
The government has arrived
…just another day?
• Establish the purpose of their visit
o Review inspectors credentials and write it down
o Request the Notice of Inspection (e.g. Form 482)
o Routine inspection or Investigational (e.g. complaint/recall)
• Identify a home base (conference room)
• Identify who will be the main point of contact
• Senior mgmt involvement and necessary resources
‘at the ready’ to obtain documentation or facilitate
a request
• Always escort the inspector
• Don’t try to delay the inevitable
• Be honest, be helpful, be smart
What is expanded records access?
• Original FD&C act did not include the provision to
inspect records
• FDA now has authority to review and copy
documents
• FSMA requires that FDA inspectors be given access
to any records or other documents that it
“reasonably believes” may relate to whether or not
a food may be adulterated and presents a
reasonable likelihood of serious adverse health
consequences or death.
Do not give Originals
Good documentation practices is critical
Freedom of Information Act (FOIA)
• The general public must make a request under the
Freedom of Information Act (FOIA) in order to
obtain certain FDA documents requiring redaction
• Exempt are certain documents that contain
company’s trade secrets or confidential
commercial information
• Stamp Confidential & Proprietary on documents
Collecting Evidence
• Factory Swabbing
o To split or not to split?
• Product Sampling
o Receipt of samples collected
o Placing product on hold
• Pictures
o They do not have to request permission
o Don’t refuse but should not be excessive (exhibit only)
• Placing equipment on hold
o Understand the specific violations and determine course to correct
• Placing food products on hold
Administrative Detention
Administrative Detention
• The objective of detention is to protect the public
by preventing movement in intrastate commerce of
a food that FDA has reason to believe is
adulterated or misbranded, while FDA institutes
appropriate action
• Place product on immediate hold
• Additional sampling of food may occur
• Not to exceed 20 calendar days unless further
seizures will be taken
• Movement can only be with FDA supervision
• FDA will send termination of detention –
if time expires then it is deemed released
What is an FDA Form 483?
• Issued at the conclusion of an inspection
• Notice of Inspectional Observations – should be
clearly defined, specific and significant
• Signed by the highest authority in the company
available
What do you need to do?
• Record all the inspector’s findings &discussion points
• Understand each objectionable condition of
violation
Top 483’s in Food
Frequency
Short Description
Reference
422
Lack of effective pest exclusion
21 CFR 110.35(c)
350
Sanitation monitoring
21 CFR 123.11(b)
322
Screening of pests
21 CFR 110.20(b)(7)
244
HACCP plan implementation
21 CFR 123.6(b)
237
Floors, walls and ceilings
21 CFR 110.20(b)(4)
235
Buildings/sanitary
21 CFR 110.35(a)
202
199
198
Critical limits
Monitoring Adequacy
Critical Control Limits
21 CFR 123.6(c)(3)
21 CFR 123.6(c)(4)
21 CFR 123.6(c)(2)
194
Manufacturing conditions
21 CFR 110.80(b)(2)
187
No HACCP plan
21 CFR 123.6(b)
Re-inspection Fees
• An inspection that was classified as a an Official
Action Indicated (OAI) and where the FDA
determines non-compliance related to food safety
which requires verification of corrective actions
• $237/hour + related costs (until September 30, 2014)
• “Related costs” means all expenses,
(i) arranging, conducting, and evaluating the
results of re-inspections; and
(ii) assessing and collecting re-inspection fees
under this section
Reference Documents
• Investigations Operation Manual (IOM) 2013
http://www.fda.gov/ICECI/Inspections/IOM/default.htm
• Food Safety Modernization Act (FSMA)
https://www.govtrack.us/congress/bills/111/hr2751/text
• FSMA Domestic Facility Risk Categorization (2012)
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm295345.htm
• Guidance for Industry - Re-inspection Fees
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsR
egulatoryInformation/FoodDefense/ucm274176.htm
• FDA’s Draft Approach for Designating High-Risk Foods as Required by
Section 204 of FSMA (February 2014)
http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM
380212.pdf
• FDA’s Guidance on Administrative Detection of Foods
http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM342591.pdf
• FDA’s FY2013 Inspectional Observations Summaries
http://www.fda.gov/ICECI/EnforcementActions/ucm381526.htm#foods
Questions