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FSMA & FDA Regulatory Compliance

We help food businesses prepare for FDA inspections and stay ahead of FSMA compliance requirements, including gap assessments, 483 response support, and corrective action follow-up. We work with clients in Florida, across the United States, and internationally.

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Ready Before FDA Walks Through the Door

An FDA inspection or FSMA compliance review can surface gaps you didn’t know existed. We run the assessments, prepare your documentation, and support you directly if FDA issues a 483 or requires corrective action. Browse the services below, or reach out and we’ll review where your compliance program currently stands.
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Case Studies

FSMA & FDA Regulatory Compliance

Food safety programs built specifically for farm, produce, and packinghouse operations, from field practices through packing and worker hygiene.

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FSMA Compliance & Gap Assessments

Review your current food safety program against FSMA preventive controls or produce safety requirements to find what's missing. This gives you a clear list of fixes before the FDA finds the gaps during an inspection.

FDA Inspection Preparation & Support

Get your documentation, facility, and staff ready for an upcoming FDA inspection. We walk through what an investigator typically looks for so nothing catches your team off guard.

FDA Corrective Action & Compliance Support

Build and implement the corrective actions needed to resolve compliance issues identified by FDA or during an internal review. We help make sure the fix actually addresses the root cause, not just the symptom.

FDA 483 / 483a Response Support

Respond formally to FDA observations within the required timeframe, with a corrective action plan for each item listed. A well-documented response is one of the biggest factors in how FDA proceeds afterward.

Regulatory Documentation Review

Review your existing compliance documentation for completeness and accuracy against current FDA and FSMA requirements. This catches outdated or missing records before an inspector does.

Internal Food Safety Compliance Assessments

Run an internal assessment that mirrors what an FDA investigator would look for during a real inspection. This lets you correct issues on your own timeline instead of under inspection pressure.

Faq

Frequently Asked Questions

An FDA Form 483 lists observations an investigator made during an inspection that may violate FDA regulations. If you receive one, you should respond in writing within the timeframe FDA provides, addressing each observation with a specific corrective action.
A FSMA compliance gap assessment reviews your current food safety program against FSMA preventive controls or produce safety requirements to identify what is missing or out of date. It gives you a clear list of what to fix before FDA finds it during an inspection.
Yes. We help businesses based in Florida as well as companies across the United States and internationally prepare for FDA inspections.
Preparing for an FDA inspection means reviewing your documentation for completeness, walking the facility for physical compliance issues, and making sure staff know how to respond to an investigator's questions. A mock inspection or internal assessment beforehand often surfaces issues you can fix in advance.
A Form 483 is issued at the end of an inspection and lists observations, while a warning letter is a more formal enforcement action FDA issues after reviewing those observations, usually when a response was inadequate or violations are more serious. A warning letter typically carries more significant consequences if not resolved.
FDA generally expects a written response within 15 business days of receiving a Form 483, though this can vary by case. Responding promptly with a specific corrective action plan is one of the biggest factors in how FDA proceeds afterward.
Yes. We run internal food safety compliance assessments that mirror what an FDA investigator would look for, so issues get identified and corrected before an actual inspection.
Yes. We help businesses respond to warning letters, build the corrective action plans FDA expects, and update documentation to resolve the underlying issues.