Is Your Facility Ready for an FDA Inspection?
An FDA inspection can be announced with as little as a phone call the morning it begins — or no notice at all. For most dietary supplement, cosmetics, food, and medical device companies, the question is never if the FDA will inspect, but when. And the difference between a smooth inspection and a Form 483 observation sheet full of findings is preparation.
Capote Law Firm helps companies prepare for FDA facility inspections before the investigator walks through the door. We identify compliance gaps, strengthen your documentation, train your staff, and ensure that when the FDA arrives, you are ready.
Don’t wait for a Form 483 to find your gaps. Call (786) 207-1174 or schedule a free consultation to begin your inspection preparation today.
What Types of FDA Inspections Should You Prepare For?
Routine Surveillance Inspections
The FDA conducts routine surveillance inspections of registered facilities on a risk-based schedule. Dietary supplement facilities are typically inspected every few years. Food facilities subject to FSMA are inspected based on risk classification. Cosmetics facilities are increasingly subject to inspection under MoCRA. Medical device facilities are inspected based on device classification and compliance history.
For-Cause Inspections
For-cause inspections are triggered by a specific event — a consumer complaint, an adverse event report, a tip to the FDA, media coverage, or a related enforcement action against a competitor or supplier. These inspections are more targeted and more likely to result in findings. If you have received a warning letter or have a compliance issue you are aware of, a for-cause inspection may be imminent.
Pre-Approval Inspections
Companies seeking FDA approval for new drug applications (NDAs) or abbreviated new drug applications (ANDAs) may face pre-approval inspections of manufacturing facilities to verify that the facility can produce the product consistently and in compliance with cGMP.
What FDA Investigators Look For
FDA investigators follow specific inspection protocols based on your product category. Common areas of focus include:
- Standard Operating Procedures (SOPs): Are your SOPs current, complete, and actually being followed? Investigators will ask to see your SOPs and compare them to actual practice on the floor.
- Batch records: Are batch records complete, accurate, and retained in accordance with regulatory requirements? Investigators review batch records for completeness and will flag missing signatures, incomplete data, or unexplained corrections.
- Testing and specifications: Are you testing finished products against established specifications? Are you testing incoming components for identity? Are your specifications appropriate for the product?
- Personnel training: Are employees trained on current SOPs? Are training records documented and retained?
- Facility and equipment: Is the facility clean, orderly, and maintained? Is equipment calibrated and qualified? Are pest control records current?
- Complaint handling: Do you have a written complaint handling procedure? Are consumer complaints documented and investigated?
- Supplier qualification: Have you qualified your component suppliers? Do you have certificates of analysis on file?
- Labeling controls: Are label controls in place to prevent label mix-ups? Is your label compliant with applicable regulations?
How Capote Law Firm Prepares Your Facility
- Mock FDA inspection: We conduct a simulated FDA inspection of your facility, reviewing your documentation, walking your floor, and interviewing key personnel — the same way an FDA investigator would. We provide a written report of every finding, categorized by severity.
- Gap analysis and remediation plan: Based on the mock inspection, we develop a prioritized remediation plan. We identify what needs to be corrected before an inspection, what can wait, and what requires immediate action.
- SOP review and development: We review your existing SOPs for regulatory compliance and completeness. Where gaps exist, we help you develop or revise procedures that satisfy FDA requirements and reflect your actual practices.
- Staff training: We train your production, quality, and management staff on FDA inspection expectations — what to say, what not to say, how to respond to investigator questions, and how to handle requests for documents.
- Documentation audit: We review your batch records, training records, complaint logs, and other required documentation for completeness and compliance before an investigator sees them.
- Ongoing compliance monitoring: We can serve as ongoing regulatory counsel, conducting annual internal audits and advising on regulatory changes that affect your facility.
What Happens If You Are Not Prepared
An unprepared inspection almost always results in a Form 483. A poorly handled Form 483 response often results in a warning letter. And a warning letter that is not resolved effectively can lead to import alerts, product seizures, injunctions, or consent decrees that shut down operations.
The cost of proper inspection preparation — in time and legal fees — is a fraction of the cost of managing an enforcement action after the fact. Companies that invest in preparation consistently achieve better inspection outcomes than those that react after an investigator arrives.
Frequently Asked Questions
How much notice does the FDA give before an inspection?
For most facility inspections, the FDA provides little to no advance notice. Investigators may call the morning of the inspection or simply show up at your door. Some inspections are pre-announced, particularly for international facilities or complex pre-approval inspections, but you should never assume you will have advance warning.
Can I refuse an FDA inspection?
You have the right to ask for the investigator’s credentials and to verify their identity. You cannot legally refuse an inspection of a registered facility — doing so constitutes a prohibited act under 21 U.S.C. § 331(f) and can result in immediate legal consequences. You can and should have legal counsel present during the inspection.
Should I have an attorney present during an FDA inspection?
Yes. Having FDA regulatory counsel present during an inspection — or on call during an inspection — is strongly advisable. An attorney can advise you in real time on how to respond to investigator questions, what documents to provide and how, and how to handle requests that may go beyond the scope of the inspection.
How long does an FDA inspection take?
FDA inspections vary widely in length. A routine surveillance inspection of a small dietary supplement facility might take one to two days. A complex for-cause inspection of a pharmaceutical manufacturer can take several weeks. The length depends on the size of your operation, the complexity of your products, and any findings the investigator encounters.
Ready to prepare? Call (786) 207-1174 or schedule a free consultation. Serving dietary supplement, cosmetics, food, and medical device companies nationwide.