How to Successfully Manage an FDA High Risk Food Inspection: 2-Day In-Person Seminar

By: Brian Hendrickson, Director, BPHendrickson Consulting LLC; Retired FDA National Food Expert
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Course Description:

This seminar will present an overview of proactive measures that food facilities that manufacture, process, pack or hold human food should take to be audit-ready all the time, such as:

  • Performing a hazard analysis
  • Developing and implementing adequate and effective HACCP plans and food safety plans (under FSMA)
  • Performing end-product and/or environmental sampling
  • Auditing suppliers of high risk food ingredients and/or sampling and testing incoming ingredients


It will identify what high risk foods are in relation to food safety and current FDA regulations applicable to the processing and packing of high risk foods. It will give special emphasis to the processing of low acid canned foods (Part 113), seafood (Part 123), juice (Part 120) and dry read to eat (RTE) foods (Part 117 – proposed rule under FSMA).

Further, the course will provide valuable insights into what FDA investigators focus on during FDA high-risk food inspections, the most common types of deficiencies that high-risk food processors have been cited for on FD Form 483 and how to act, especially in response to inspectional observations by investigators and follow-up correspondence with FDA. The seminar will provide insights on what facilities that manufacture, process, pack and hold human food can expect when FDA’s proposed new preventative control regulation (21CFR Part 117) becomes effective as a final rule sometime in 2015. The seminar will conclude with a presentation on the control of salmonella in low moisture foods plus a class exercise pertaining to the development of a food safety plan for a dry ready to eat (RTE) food.

In all, the primary areas covered in the course are:

  • What characterizes high risk foods as compared to low risk foods
  • Brief overview of FDA high risk food regulations: (a) 21 CFR Part 113 (LACF-HACCP Based), 21CFR Part 114 (Acidified Foods – HACCP Based), 21CFR Part 123 – Seafood (HACCP); 21CFR Part 120 – Juice (HACCP); Preventative Control Regulation – Proposed under FSMA – 21 CFR Part 117
  • The importance of being audit-ready all the time
  • The importance of well written, effective standard operating procedures
  • The importance of conducting a thorough and effective hazard analysis
  • The importance of developing and implementing adequate HACCP and food safety plans (FSMA)
  • The difference between traditional HACCP plans and food safety plans under Part 117, Subpart B and Subpart C (HARPC)
  • What FDA investigators look for during high risk food inspections
  • How to act during an FDA inspection and correspond with FDA
  • Facility registration and record establishment/maintenance/availability requirements under FSMA
  • The Reportable Food Registry (RFR) reporting requirements for facilities that manufacture, process, prepare and pack human food

Learning Objectives:

  • What high risk foods are in relation to food safety
  • What FDA regulations apply to high risk foods processed at your plant
  • The new FDA preventative control regulation under FSMA – 21CFR Part 117
  • The importance of SOPs that are effectively written and implemented
  • When a hazard analysis and HACCP plan or food safety plan are required
  • How to write and manage an acceptable HACCP plan
  • How to prepare acceptable monitoring, corrective action and verification records under HACCP and FSMA
  • What FDA investigators focus on during FDA high risk inspections
  • Examples of FDA deficiencies reported on Form 483 during high risk food inspections
  • The importance of being audit ready
  • How to act during FDA inspections and correspond with FDA after the inspection, especially in response to deficiencies cited on Form FD483

Who will benefit:

Manufacturers of food, processors, food packaging companies, warehousing and distribution companies and importers sourcing food and beverages from overseas will benfit from this seminar. The personnel who will benefit include:

  • Plant managers
  • Quality control managers and employees
  • Regulatory affairs
  • Documentation
  • Production managers and employees
  • Microbiologists
  • Scientists
  • Importers/exporters
  • Raw materials and ingredient manufacturers
  • Consultants
  • Professors of food science
  • Sales

Course Outline:

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  • 9:00 – 9:15 AM
    • What to expect during an FDA inspection
    • Being audit-ready – it’s meaning, significance and how to accomplish it
  • 9:15 – 9:30 AM
    • What high risk foods are in relation to food safety
    • What FDA is doing to define high risk foods and how that will be shared with the food industry
  • 9:30 – 11:00 AM
    • Low Acid Canned Foods- 21 CFR Part 113
      • Low acid canned food – definition
      • Significant hazards
      • A new amendment to Part 113 and how LACFs will be regulated under the new proposed Part 117
      • Your responsibilities under Part113 to prevent adulteration including C botulinum toxin formation in LACFs
      • Types of LACF processing – conventional canning (retorts) and aseptic processing
      • Process establishment (critical factors) and required records
      • Process delivery and required monitoring records
      • Container integrity - testing and required records
      • Successful management of a canned food warehouse
      • Sanitation – importance in LACF processing
      • Common FDA 483 deficiencies
      • Types of regulatory actions taken by FDA for violations of Parts 113 and 108.35 Subpart B
  • 11:00 – 11:15 AM – Break
  • 11:15 – 12:00 PM
    • Acidified Foods – 21 CFR Part 114
      • Acidified foods - definition
      • Significant hazards
      • Types of acidified food processing
      • Process establishment and required records
      • Process delivery and required monitoring records
      • Sanitation – importance in acidified food processing
      • Container integrity – testing and required records
      • The weakness of Part 117 to control food safety
      • How acidified foods will be regulated under the new proposed Part 117
      • Common FDA 483 deficiencies
      • Types of regulatory actions that have been taken by FDA for violations of Parts 114 and 108.25 Subpart B
  • 12:00 – 1:00 PM - Lunch
  • 1:00 – 1:15 PM - Break
  • 1:15 – 3:00 PM
    • Seafood HACCP - 21CFR Part 123
    • GMPs and prerequisite programs
    • Significant hazards
    • Hazard analysis
    • HACCP plan - adequacy
    • HACCP plan implementation
      • Monitoring
      • Corrective action per corrective action plan
      • Records – monitoring and corrective action records; calibration records
      • Validation – calibration; process validation; HACCP plan validation (annual audit)
    • Common FDA FD483 deficiencies
    • Types of regulatory actions that have been taken by FDA for violations of Part 123
  • 3:00 – 3:15 PM – Break
  • 3:15 – 4:15 PM
    • Juice HACCP – 21CFR Part 120
      • GMPs and prerequisite programs
        • Significant hazards
        • Hazard analysis
        • HACCP plan – adequacy
      • HACCP plan implementation
        • Monitoring
        • Corrective action per corrective action plan
        • Records – monitoring and corrective action records; records of verification and validation activities
        • Validation – calibration; process validation: HACCP plan validation (annual audit and analysis)
      • Common FDA 483 deficiencies
      • Types of regulatory actions that have been taken by FDA for violations of Part 120
  • 4:15 – 4:30 PM - Questions
Day Two (8:30 AM – 4:30 PM)
  • 8:30 - 10:00 AM
    • The new FDA proposed preventative controls regulation under FSMA – 21CFR Part 117
      • An overview of Subparts B and C (HARPC)
      • How it differs from traditional HACCP
      • A scenario involving a Class I Recall of a dry RTE food, follow-up inspection of the processing facility by FDA and corrective action required by the offending facility under Part 117 to ensure that serious hazards reasonably likely to occur are significantly minimized or prevented
      • Insights of what processing facilities can expect for regulatory compliance under Part 117
  • 10:00 – 10:15 AM - Break
  • 10:15 – 10:30 AM
    • The reportable food registry and how it affects food processors
  • 10:30 – 12:00 PM
    • Control of salmonella in low moisture foods -( PPT presentation ) – this presentation correlates with the requirements of the new FDA preventative control regulation under FSMA – Part 117, Subparts B and C
  • 12:00 - 1:00 PM - Lunch
  • 1:00 - 3:00 PM
    • Class Exercise
  • 3:00 - 3:30 PM
    • Discuss Exercise
  • 3:30 - 4:00 PM
    • How to act during FDA inspections and correspond with FDA after the inspection, especially in response to deficiencies cited on Form FD483.
  • 4:00 - 4:30 PM
    • Questions, Wrap-up

Meet Your Instructor

Brian Hendrickson-90X112
Brian Hendrickson,
Director, BPHendrickson Consulting LLC; Retired FDA National Food Expert

Brian Hendrickson is a retired FDA National Food Expert with more than 35 years’ experience with the agency. As a national expert, he helped develop FDA regulatory policy for high-risk foods and trained FDA and state food inspectors nationwide in food technologies and related hazards, FDA regulations and inspection techniques. He has conducted FDA inspections of food manufactures internationally. Since his retirement in 2011, Mr. Hendrickson has been self-employed as a food industry consultant, served a 3-year appointment as assistant professor of food science at Purdue University and taught food safety courses at Purdue and 4 other universities nationwide.

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