Handling Regulatory Inspections

Denise WebsterFresh & EasyApril 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? o Inspections are increasing (e.g. high-risk sites)o Records access is broader and more complexo Fees if a re-inspection is requiredo Legal & Reputation risk to your company and brand - if you

don’t get it right!

• Do you have a plan?

Likelihood of Inspection

• 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 RiskCriterion 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

• 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 visito 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

• 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 OriginalsGood documentation practices is critical

What is expanded records access?

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 Samplingo Receipt of samples collectedo Placing product on hold

• Pictureso They do not have to request permissiono Don’t refuse but should not be excessive (exhibit only)

• Placing equipment on holdo Understand the specific violations and determine course to correct

• Placing food products on holdAdministrative 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 FoodFrequency

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)

202199198

Critical limitsMonitoring AdequacyCritical 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) 2013http://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 Feeshttp://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/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/UCM380212.pdf• FDA’s Guidance on Administrative Detection of Foodshttp://www.fda.gov/downloads/Food/GuidanceRegulation/UCM342591.pdf• FDA’s FY2013 Inspectional Observations Summarieshttp://www.fda.gov/ICECI/EnforcementActions/ucm381526.htm#foods

Questions