Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!

Know your rights during an FDA inspection

It is essential for dairy companies to know where FDA’s authority ends

By John T. Allan, Emily Lyons
food safety inspection
March 12, 2018

Food Safety Modernization Act (FSMA) regulations represent a paradigm shift in how food is regulated in the United States to protect consumers from foodborne illness. The act and its corresponding regulations not only place more responsibility on food manufacturers, but also provide FDA with substantial new authority to use when inspecting facilities.

As FDA has shifted its focus to implementing the FSMA regulations and inspecting against those standards, it is essential for dairy companies to know where FDA’s authority ends and to be well prepared for FSMA inspections. Two of the most commonly asked questions we receive revolve around FDA’s authority over records access and photography during inspections.

Records access

Historically, FDA investigators and state inspectors working on behalf of FDA had very limited rights to demand access to company records during routine inspections. FSMA significantly changed this approach by granting FDA substantial records access. Now, investigators can access and copy a facility’s Food Safety Plan (FSP) and other records relating to the manufacturing, processing, packing and holding of food.

FDA is energized and ready to use its new records access authority because these records help the agency determine how a company operates when investigators are not present. In general, FDA investigators may review and copy all records associated with your FSP, including a facility’s hazard analysis, descriptions of preventive controls, environmental and product testing records, and corrective actions records.

They are not entitled to review or copy the following types of records: recipes, sales or pricing information, financial data, product research and consumer complaint information, if not included within the FSP. However, they may request these documents; therefore, facility representatives should be prepared to respectfully decline access, when appropriate, to ensure FDA is not accessing records that are outside of its legal authority.

A picture says 1,000 words

Requests for photography may be handled the same way. A company is not required to allow FDA to take photographs during an inspection, but it may choose to do so.

Although FDA investigators are adamant that they have a right to take photographs during inspections, neither the Federal Food, Drug and Cosmetic Act nor case law provides definitive legal authority to do so. FSMA did not change this. Nonetheless, FDA investigators are instructed to take photographs without permission and to press the matter even if the company objects.

FDA uses photographs to help supplement observations in its inspection reports, document deviations from good manufacturing practices and record where environmental swabs were collected. Companies are understandably leery of photography because a photo could capture proprietary aspects of a facility, could cause a safety hazard in some circumstances or may be taken out of context and used in court against the company.

We strongly recommend that all companies, working closely with their legal counsel, establish a firmwide policy with respect to the taking of photographs or video recordings inside their facilities. If your company adopts a policy that prohibits photography, the policy should be clearly, but respectfully, explained to the investigator during the pre-inspection meeting to head off any attempts to bring a camera onto the production floor. Additionally, your representative should clearly convey that the facility is not refusing an inspection; it is merely following company policy.

If your company decides to allow photography by an FDA investigator, a facility representative should take similar photos to develop your own record of inspection and possibly generate additional context for the photos, if necessary.

As FDA follows its mantra “to educate before and while we regulate,” IDFA encourages dairy food companies to understand their rights and be prepared before an inspection occurs. Doing so will help ensure inspections proceed more smoothly — for both the company employees and FDA investigators.  

This article was originally posted on www.dairyfoods.com.
KEYWORDS: FDA inspections FDA regulations plant safety

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

John T. Allan is the vice president for regulatory affairs and international standards at the International Dairy Foods Association, Washington, D.C. He directs all aspects of IDFA's food safety training initiatives, leads efforts related to product safety issues and has responsibilities in federal and state regulatory affairs.
Emily Lyons is the director of regulatory affairs and counsel for the International Dairy Foods Association, Washington, D.C.

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Food Type
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Facilities
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    Contamination Control
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Manage My Account
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • Two men standing in a produce storage facility having a discussion.
    Sponsored byOrkin Commercial

    Staying Compliant With FSMA

  • Deli Salads
    Sponsored byCorbion

    How Food Safety is Becoming the Ultimate Differentiator in Refrigerated and Prepared Foods

Popular Stories

FoodSafetyMattersFinal-900x550-(002).jpg

Ep. 195. Dr. Christopher Daubert: The Value of a Food Science Education

Students returning their lunch trays in a cafeteria

California Bill Would Remove Ultra-Processed Foods from School Lunches

Map of part of the African continent

Africa Food Safety Agency Could Be Fully Functional by 2026

Events

June 26, 2025

How to Design and Conduct Challenge Studies for Safer Products and Longer Shelf Life

Live: June 26, 2025 at 2:00 pm EDT: During this webinar, attendees will learn how to conduct challenge studies for microbial spoilage and pathogen growth, including the common challenges encountered, laboratory selection, and use of predictive models.

May 11, 2026

The Food Safety Summit

Stay informed on the latest food safety trends, innovations, emerging challenges, and expert analysis. Leave the Summit with actionable insights ready to drive measurable improvements in your organization. Do not miss this opportunity to learn from experts about contamination control, food safety culture, regulations, sanitation, supply chain traceability, and so much more.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • RulesRegs.jpg

    Manage food safety data

    See More
  • FDA inspection

    What you need to know before an FDA visit

    See More
  • FDA’s Right to Take Photographs in Your Facility: Or Not

    See More

Events

View AllSubmit An Event
  • April 15, 2025

    FSMA 204: How to Achieve Traceability and Transparency Along Your Supply Chain

    On Demand: In this webinar, representatives from the fresh produce and foodservice distribution sectors, as well as a traceability-focused industry organization, will discuss the steps companies should take now to ensure they are prepared for FSMA 204 compliance.   
View AllSubmit An Event
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing