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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced it will expand its use of unannounced inspections at foreign manufacturing facilities. This shift is part of the FDA’s ongoing effort to strengthen oversight of imported medical products and food—bringing foreign inspection standards in line with domestic ones.
Read the official announcement from FDA →
Why the FDA Is Increasing Surprise Inspections Overseas
Historically, the FDA provided advance notice for most inspections of foreign manufacturers—sometimes weeks in advance. However, recent data showed that inspections with notice revealed significantly more compliance issues than domestic unannounced inspections, raising concerns about manipulated or concealed deficiencies.
Key drivers behind the FDA’s decision include:
- Eliminating discrepancies between domestic and international inspection protocols
- Reducing the opportunity for facility preparation or data alteration
- Enhancing the agency’s ability to ensure products meet Good Manufacturing Practices (GMP) and regulatory expectations
What Foreign Manufacturers Need to Do to Stay Compliant
With little or no notice now expected before an FDA inspection, foreign manufacturers must shift to a “compliance-at-all-times” mindset. The cost of being unprepared—especially for those exporting to the U.S.—can include 483 observations, import alerts, or refusal of entry.
Key Compliance Steps to Take Immediately:
- Conduct internal GMP audits to ensure systems and records meet FDA standards
- Implement mock FDA inspections to simulate surprise visits and train teams
- Ensure quality documentation is inspection-ready at all times
- Reinforce data integrity practices to prevent any sign of manipulation or lack of transparency
Why Inspection Readiness Is Now a Competitive Advantage
In a regulatory environment that rewards transparency and punishes delay, having a proactive inspection strategy isn’t just about risk management—it’s about business continuity and market access.
Companies that are prepared can:
- Respond calmly and accurately under pressure
- Avoid regulatory delays or costly disruptions
- Strengthen their global reputation for compliance
How RCA Helps You Prepare for Unannounced FDA Inspections
At Regulatory Compliance Associates (RCA), we partner with life science companies around the globe to ensure they’re inspection-ready at all times. Our experts include former FDA and industry professionals who know exactly what investigators look for.
RCA’s Inspection Readiness Services Include:
- GMP gap assessments for foreign and domestic facilities
- Mock FDA inspections tailored to your operations and risk profile
- Data integrity reviews to uncover hidden vulnerabilities
- On-site training for regulatory inspection best practices
- Real-time inspection support from regulatory experts
Whether you’re a pharmaceutical manufacturer, medical device producer, food supplier, or combination product company, RCA helps you transform unannounced inspections from a threat into a strategic differentiator.
Medical Device Compliance Training & Inspection Readiness
Pharmaceutical Compliance Training & Inspection Readiness
Don’t Let a Surprise Inspection Derail Your U.S. Market Access
The FDA’s expanded authority to conduct unannounced inspections is a clear signal: global compliance expectations are rising. Companies that adapt quickly will thrive—those that don’t may find themselves locked out of critical markets.
Partner with RCA today to prepare your facility for unannounced inspections. We’ll help you stay compliant, inspection-ready, and confident—no matter when the FDA arrives.
Use the contact us form below to get started now.
