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 complex o Fees if a re-inspection is required o Legal & Reputation risk to your company and brand - if you dont 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 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 FDAs 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 Dont 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 Dont 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 Originals Good 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 companys 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 Dont 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
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 inspectors findings &discussion points Understand each objectionable condition of violation
Top 483s in Food FrequencyShort DescriptionReference 422Lack of effective pest exclusion21 CFR 110.35(c) 350Sanitation monitoring21 CFR 123.11(b) 322Screening of pests21 CFR 110.20(b)(7) 244HACCP plan implementation21 CFR 123.6(b) 237Floors, walls and ceilings21 CFR 110.20(b)(4) 235Buildings/sanitary21 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) 194Manufacturing conditions21 CFR 110.80(b)(2) 187No HACCP plan21 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 FDAs 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 FDAs Guidance on Administrative Detection of Foods http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM342591.pdf FDAs FY2013 Inspectional Observations Summaries http://www.fda.gov/ICECI/EnforcementActions/ucm381526.htm#foods