Scope of Inspection - Food and Drug Law Institute

What Does FDA Consider During
a Food Facility Inspection?
How will FSMA Change This?
FDLI Enforcement, Compliance, and
Litigation Conference
December 9, 2014
Miriam Guggenheim, Covington & Burling LLP
Elizabeth Fawell, Hogan Lovells
Lisa Heinzerling, Georgetown Law
What does FDA consider during
a food facility inspection?
• GMPs
– Allergen controls are a priority
• Compliance with any special programs
– Seafood/juice HACCP
– Low acid/acidified foods
– Infant formula
• Labeling/claims
Scope of Inspection
• Broad scope of physical inspection:
– FDA inspector may “enter, . . . any factory, warehouse, or
establishment in which food[s] . . . are manufactured, processed,
packed, or held, for introduction into interstate commerce” or any
“vehicle, and all pertinent equipment, finished an unfinished
materials, containers, and labeling therein.”
• Currently, a limited scope of records inspection:
– records documenting the movement of food in interstate
– records relating to reportable food registry reports
– records relating to compliance with special programs (seafood,
juice, bottled water, infant formula, LACF/AF)
– limited records access authority in SAHCODHA situations
• FSMA will turn this upside down
Hazard Analysis and Preventive
• FSMA requires that facilities put in place and document
a food safety plan that describes the company’s:
– hazard analysis
– preventive controls
– procedures to monitor effectiveness, corrective actions, and
methods to verify effectiveness.
• Facilities must maintain records relating to the plan and
these activities for at least two years and make them
available to FDA upon written or oral request, including
during routine inspections
Hazard Analysis
• Must identify/evaluate known or reasonably
foreseeable hazards that may be associated
with a facility, including
– biological, chemical, physical,
radiological hazards
– natural toxins
– pesticide and drug residues
– unapproved food/color additives
– allergens
– hazards naturally occurring or
intentionally introduced
• Must document analysis
Preventive Controls
• Must identify and implement validated
preventive controls
– to significantly minimize or prevent identified hazards
• Must monitor and verify that preventive controls
are effective, and take corrective action when
• Preventive controls are . . .
– risk-based procedures, practices, and processes
– that a person knowledgeable about safe food
manufacturing/packing/holding would employ
– consistent with current scientific understanding of
safe food manufacturing/handling
Implications of FSMA for
• Inspections will be very heavily document-focused
• Violations will occur for failure to conduct and document
appropriate analyses and procedures
– Consider history regarding warning letters for dietary supplement
GMP violations
Implications of FSMA for
• Companies’ decisions about risks and their
control will become much more exposed to
scrutiny (and second-guessing?) by inspectors
– Flexibility in FSMA/rulemaking may be a doubleedged sword
• “Risk based”?
• “Reasonably foreseeable”?
• “As appropriate to the facility”?
– Rulemaking and guidance development process is
the time to seek clarity to (hopefully) avoid debates
with inspector
FSVP Records
• Determination of verification activity/risk evaluation
• Documentation of the verification activity (FDA sets out
minimum requirements for the contents):
– Audits
– Testing
– Review of records
– Letters from customers/suppliers
• Corrective actions
• “List” of suppliers
 Key Issue: Where review will take place
Sanitary Transportation of Food
• FDA is not requiring maintenance of records for each
• Shippers must maintain:
– Records that document the sanitary and temperature control
requirements specified to the carrier
• Carriers must maintain:
– Any written agreements with the shipper that assign
responsibility for temperature monitoring or regarding bulk
vehicle cargoes and cleaning
– Written procedures
– Training records
Other FSMA Issues
• Suspension of Registration
• Mandated inspection frequency based on
• Reinspection fees
How Will Inspections Change?
• New Inspection Paradigm
– FDA to develop inspection cadre specially
trained in and devoted to food inspections
– Systems-based approach
• “Culture of food safety”
– Heavily dependent on records review
– Closer integration of field inspectors and HQ
– Rapid enforcement action if high risk to public
health identified
FDA Culture is Changing
• FSMA implementation is occurring just as FDA culture is
• FDA is rapidly becoming:
– More inspection-oriented
– More enforcement-minded
FDA is More InspectionOriented
• FDA is:
– Conducting more domestic inspections (with the
– More strategic about selecting inspection sites
– Posting some 483s on website
– Expanding definition of “high risk”
– Testing more, both environmental and finished
– Increasing oversight of imports, especially
ingredients, and conducting foreign on-site
Enforcement is on the Rise
Increase in Warning Letters
Increase in court injunctions
Heightened use of Import Alerts
Expanded use of Park Doctrine on the
• New “deficiency letters”?
Impact for Inspections
• Inspections have already changed:
– FDA is energized and persistent and will note all possible
violations as inspectional observations
– FDA will demand access to records the agency lacks the
legal authority to access
– FDA will try hard to take photographs even without
express legal authority
– Inspections involve comprehensive environmental
sampling (“swab-a-thon”)
What to Do
• Know your rights
• Start preparing now for FSMA inspections