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

2

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

commerce– 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 down3

Hazard Analysis and Preventive Controls

• 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

4

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

5

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 needed

• 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/handling6

Implications of FSMA for Inspections

• 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

7

Implications of FSMA for Inspections

• 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 double-

edged 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

8

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

9

Sanitary Transportation of Food

• FDA is not requiring maintenance of records for each shipment

• 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

10

Other FSMA Issues

• Suspension of Registration• Mandated inspection frequency based on

risk• Reinspection fees

11

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

experts– Rapid enforcement action if high risk to public

health identified12

13

FDA Culture is Changing

• FSMA implementation is occurring just as FDA culture is changing

• FDA is rapidly becoming:– More inspection-oriented– More enforcement-minded

FDA is More Inspection-Oriented

• FDA is: – Conducting more domestic inspections (with the

states)– More strategic about selecting inspection sites– Posting some 483s on website– Expanding definition of “high risk”– Testing more, both environmental and finished

product– Increasing oversight of imports, especially

ingredients, and conducting foreign on-site inspections

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

horizon• New “deficiency letters”?

16

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

17