Updated: 1/21/2025
1 ) What part of the FDA conducts food facility inspections?
The enactment of the Food Safety Modernization Act (FSMA) expanded the FDA’s inspection authority significantly. Initially, FDA inspections of farms occurred mainly during foodborne illness investigations or findings of potential food adulteration. Now, inspections also include routine inspections and occur more frequently sometimes without prior notice. These inspections are conducted by the Office of Human Food Inspectorate, part of the Office of Inspections and Investigations (OII). As of October 1, 2024, the OII replaced the Office of Regulatory Affairs (ORA).
State and local agencies also partner with the FDA to conduct inspections under cooperative agreements. These agencies might follow different protocols, but they generally align with FDA standards.
2 ) How many inspectors should you expect to see during an inspection? Is it typical for inspectors to come from different offices (state, federal)? What do you do when the inspectors arrive? What information are you entitled to?
Number of inspectors: The number of inspectors may vary depending on the scope of the inspection. Inspections can also be opportunities for training new inspectors, inspectors to learn new types of facilities and/or inspectors to calibrate across different offices.
State and federal collaboration: Inspections may involve personnel from both FDA and state agencies working under cooperative agreements.
What to do when inspectors arrive:
- Inspectors must present a Notice of Inspection (Form FDA-482 or FDA-482(c)) to your designated company contact before proceeding with the inspection.
- This form includes the inspection date, the name and title of the firm representative, the firm’s name and location, and the authority granted by the Food, Drug, and Cosmetic Act (FD&C Act).
- It must be signed by the inspector and display the name and address of their District Office.
- If state or local officials conduct the inspection and do not provide this form, document their credentials and any information about their inspection authority.
- Keep a copy of the Notice of Inspection for your records.
3 ) What are the different types of inspections? VIA vs OIA?
The FDA and its state partners conduct three main types of inspections:
- Surveillance Inspections: Routine, proactive inspections to ensure compliance with FDA regulations.
- Compliance Follow-Up Inspections: Conducted to verify corrective actions taken after previous observations.
- For-Cause Inspections: Triggered by specific events, such as a foodborne illness outbreak or consumer complaint.
Inspection classifications:
Inspections are classified into three categories based on findings:
- No Action Indicated (NAI): No objectionable conditions or practices were observed.
- Voluntary Action Indicated (VAI): Objectionable conditions or practices were found, but no regulatory action is recommended.
- Official Action Indicated (OAI): Regulatory or administrative actions are recommended based on significant violations.
The final classification (OAI) considers observations made during the inspection, the facility’s response to Form FDA-483, and corrective actions taken.
4 ) Can we explain the difference between an observation (483) versus a violation?
An FDA Form 483 is issued at the end of an inspection when an investigator observes conditions that may violate the FD&C Act or related regulations. It lists observations in order of risk significance and typically includes:
- A citation of the relevant law, regulation or act.
- Specific details about the observed conditions.
Key distinctions:
- Observation: Potential issues noted by inspectors. A 483 does not constitute a violation or final regulatory action.
- Violation: Determined after further evaluation of the 483 and other evidence, which may result in regulatory or administrative action.
You should review 483 observations carefully and respond promptly with proposed corrective actions.
It’s important to realize that not all 483s are the same! Jennifer McEntire recently posted a story regarding the mischaracterization of the 483, which in plain words offers a clear explanation of what 483 forms are or aren’t.
5 ) What are common observations during inspections? FDA publishes a summary of inspection data, where can I find it?
Common observations during inspections include issues related to:
- Sanitation and hygiene practices.
- Documentation and record-keeping.
- Equipment maintenance and calibration.
The FDA publishes a summary of inspection data, including final classifications, in its FDA Inspection Database (FDA Dashboards – Inspections). The agency maintains an inspection database that includes final inspection classifications (updated weekly). Once an inspection has been classified and it is considered closed it is added to this database.
In 2024, approximately 74% of inspections resulted in “No Action Indicated” (NAI), while less than 2% resulted in “Official Action Indicated” (OAI).More statistics can be obtained from the FDA’s data dashboard to provide more context about inspection findings.
Table 1. 2024 Food/Cosmetic inspection based on findings.
Product Type |
Classification |
Total Inspections |
Percentage |
Food/Cosmetics |
VAI |
2448 |
25% |
Food/Cosmetics |
OAI |
169 |
2% |
Food/Cosmetics |
NAI |
7359 |
74% |
|
All Categories |
9976 |
|
6 ) How do I prepare for when the inspector arrives at my facility?
Preparation is key. Companies should establish an Inspection Team and written procedures to manage inspections effectively. Key responsibilities include:
- Escort Protocol: Ensure inspectors are escorted at all times while on the premises.
- Point of Contact: Designate a Company Contact to respond to inspector questions and requests.
- Document Management: Have clear policies for disclosing records, trade secrets and confidential information.
- Use of Equipment: Be aware of policies regarding inspectors’ use of recording devices, photography and sampling procedures.
Companies should also ensure that inspectors comply with internal health and safety rules. Resources like the Western Growers FDA Inspections Manual (FDA Inspections Manual ) provide detailed guidance on planning, managing inspections and post-inspection follow-up.
7 ) What to do when a company believes the FDA has misunderstood an aspect during an inspection?
When a company identifies a potential misunderstanding during an FDA inspection, it’s important to address the issue promptly and professionally. Following these steps can help ensure the situation is resolved effectively:
- Provide a Detailed Response: Explain why you believe the observation stems from a misunderstanding. Include background information, contextual explanations and evidence to support your position. This helps FDA officials, who may not be familiar with your operations, understand your perspective.
- Maintain Professionalism: Contesting an FDA observation is acceptable, but it must be done respectfully and constructively. Ensure your response focuses on clarifying the misunderstanding rather than appearing confrontational.
- Engage with the FDA District Office: The district office oversees the inspection process and the work of field investigators. If communication with the on-site investigator does not resolve an issue, contacting the district office can help escalate and address confusion regarding inspection findings or misunderstandings.
- Document All Communications: Keep detailed records of all interactions with the FDA. Proper documentation is invaluable if further discussions or escalations are necessary.
By following these steps, companies can address misunderstandings during FDA inspections through clear communication, constructive dialogue and appropriate channels.