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FDA Inspections: Rights and Reasonableness

Denis Storey
August 15, 2019

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When preparing for an FDA inspection, it is crucial to understand your facility's core rights and responsibilities. The topic of FDA inspections is unique within legal circles, and when discussing food law, most attorneys discuss the Food Safety Modernization Act (FSMA). When it comes to inspections, the discussion begins to drift more on the Constitution and the unusual mix of privacy, consent, and other issues that come into play. You don't need a law degree to understand FDA inspections. Let TraceGains provide some insight into this topic.

 The Fourth Amendment to the Constitution outlines the protection of search/seizures and often references criminal circumstances. This amendment also contains a framework of domestic inspections, so it does have relevance in FDA inspections. Let's start our examination by providing an overview of FDA Inspection fundamentals.

The Basics of an FDA Inspection 

Notification of Inspection

In 1953 congress passed the Food, Drug, and Cosmetic Act to include the Factory Inspection Amendment. This amendment requires the FDA to give manufacturers written reports of conditions observed during inspections and factory samples analysis. Form 482, a notice of inspection, precedes form 483, a summary of the inspector's observations from the inspection. In the food industry, these forms are quite famous.

FDA inspections are surprise, warrantless searches. The Factory Inspection Amendment establishes constraints for these inspections in the form of the reasonableness standard. This standard requires the agent to be reasonable in what they're doing and in their requests. The key to a smooth inspection often equates to the amount of training provided to facility staff. 

In many cases, the receptionist will be the first to greet an agent when they arrive at the facility. The inspector presents them with Form 482. The receptionist must properly understand how to react to this event. If an inspector is left waiting for any period, it could lead to the appearance of refusing an inspection. This response (technically a misdemeanor), can start the inspection off on the wrong foot. To avoid this situation, include steps within your Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs) to ensure the agent is settled, and notify the appropriate personnel.

Types of Inspections

There are two types of FDA Inspections: 

Routine Inspections occur for all FDA registered facilities. The frequency can vary by district and field office. Under FSMA, high-risk facilities or facilities producing higher risk foods will have a higher rate of inspection.

For-Cause Inspections occur during a recall or an outbreak. These are, of course, unpredictable and are also going to be very wide in scope. The FDA conducts comprehensive supply-chain inspections to determine the source of an issue, or with a recall, determining the scope of that recall. 

Re-Inspection Fees

The Food Safety Modernization Act of 2011 ushered in a tighter focus on re-inspection fees. Since its passing, the FDA has increasingly relied upon user fees to be a key component of their budgeting process. FSMA provides authorization to collect re-inspection fees for non-compliance and recall orders that follow routine and for-cause inspections.  

FDA Inspection Boundaries

FDA Inspections have two boundaries:

The Factory Inspection Amendment often uses the term "reasonable" to describe the FDA's right to inspect a facility. Phrases such as "reasonable times," "reasonable promptness," or "reasonable limits" are defined and interpreted to indicate "what's reasonable and necessary to achieve the objective of the inspection." Some of these phrases can be correlated (e.g., "reasonable time" means only during regular operating hours," however, other phrases such as "reasonable limits and manner" are more open to interpretation. 

The List of Records Deemed Outside the FDA's Jurisdiction are listed within the statues, which establish financial, sales, pricing, and personnel data outside of qualifications. 

The statute is very vague, and there is a tendency for the FDA to interpret any ambiguity in the broadest terms possible. In general, FDA authority over the boundaries of inspection is rarely challenged. The majority of businesses want to get along with the FDA, and if challenged, it is simple for the FDA to obtain a formal administrative warrant to complete the search. 

Challenging an Interpretation

The challenge arises when you disagree with the inspector making a request for inspection or making a particular interpretation during an inspection. How does someone object to an inspection to preserve a potential future challenge? Once consent for an inspection is given, there's no ability to challenge after that. It is often tricky to object without appearing to impede, delay, or refuse an inspection. Many facilities opt to let the agent carry out their inspection to receive an accurate Form 483 and obtain a precise reading of how their facility is operating.

Want to be ready for an audit or inspection at any time? For tips and best practices, download our eBook, "Are You Ready for an Audit?" here