FDA Inspection Readiness Services
Prepare Your Facility, Documentation, and Team for Successful FDA Inspections
At FDAInspections.com, we specialize in helping companies across the food, dietary supplement, cosmetic, pet product, medical device, and biologics industries achieve full FDA inspection readiness. Whether you’re preparing for a routine surveillance inspection, a Pre-Approval Inspection (PAI), a Pre-License Inspection (PLI), or a for-cause audit, we equip you with the strategies, training, and compliance systems you need to succeed.
Our mission: Ensure you are inspection-ready, confident, and fully compliant — so you can protect your products, your brand, and your future.
What Is FDA Inspection Readiness?
FDA inspection readiness means more than simply reacting to an inspection notice. It means maintaining a continuous state of operational compliance, backed by robust documentation, a trained team, and defensible quality systems. Companies that stay inspection-ready are better equipped to avoid:
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FDA Form 483 Observations
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Warning Letters
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Import Alerts
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Product recalls and facility shutdowns
Learn About FDA Inspection Procedures (FDA.gov)
Our FDA Inspection Readiness Services
1. Pre-Inspection Gap Assessments
We evaluate your current systems, documentation, and facility operations against applicable FDA regulations, identifying vulnerabilities before an inspector does.
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cGMP compliance (21 CFR Part 111, 117, 210/211, 820)
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FSMA Preventive Controls requirements
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Facility, process, and documentation reviews
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Risk-based prioritized action plans
2. Mock FDA Inspections
Simulate an FDA inspection with real-world scenarios, complete with opening meetings, document requests, facility walkthroughs, and staff interviews.
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Conducted onsite or remotely
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Full inspector-style mock audit experience
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Identification of potential 483-level findings
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Corrective action recommendations
3. SOP and Documentation Readiness
Ensure that your procedures, batch records, training records, and validation documents are audit-ready.
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SOP gap analysis and creation assistance
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Batch production and quality records review
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Training matrix validation and readiness
4. Staff Training and Inspection Protocol Preparation
Your personnel must know how to behave, communicate, and produce documentation during an FDA inspection.
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Staff training workshops
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Mock inspection interviews
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Communication protocols for inspections
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Inspection room preparation and document flow management
Why FDAInspections.com for Inspection Readiness?
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Industry-Specific Expertise – Tailored readiness plans for dietary supplements, foods, cosmetics, medical devices, pet products, biologics, and veterinary products.
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Proven, Practical Systems – Actionable advice, not academic theories.
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Confidential and Trusted – Trusted by startups, mid-size brands, and multinational companies.
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Inspection Simulation Specialists – We train you to think like an FDA investigator — and win.
We don’t just help you “prepare” — we help you master the inspection experience.
Frequently Asked Questions About FDA Inspection Readiness
Q: How far in advance should we start preparing for an FDA inspection?
A: Ideally, inspection readiness should be ongoing. However, for scheduled inspections, we recommend starting a focused readiness program at least 3–6 months in advance.
Q: Can you help if we’ve never been inspected before?
A: Absolutely! We specialize in first-time FDA facility readiness programs, from basic SOP development to full mock inspections.
Q: Are your services customized for different industries?
A: Yes. Each inspection readiness program is customized based on your specific regulatory framework (supplements, food, devices, biologics, cosmetics, pet products).
Q: Can you conduct remote inspection readiness audits?
A: Yes. We offer virtual audits, documentation reviews, and remote mock inspections, along with onsite options depending on your needs.
Contact FDAInspections.com Today
Be prepared. Be confident. Be compliant.
Let FDAInspections.com get you inspection-ready — and help protect your products, your customers, and your brand.
📧 Email: [email protected]
📞 Phone: (208) 971-6430
Request Your FDA Inspection Readiness Consultation
FDAInspections.com — Your Trusted Partner for FDA Inspection Readiness and Compliance Success.