How to Stay Inspection Ready as FDA Expands Surprise Foreign Inspections

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Since the FDA announced in May 2025 the expansion of unannounced inspections at foreign manufacturing facilities, a new regulatory landscape has emerged for companies supplying foods, essential medicines, and other medical products to the U.S. market.

The shift brings global oversight into closer alignment with domestic practices—where surprise visits are already the norm—and aims to deter practices such as records falsification or “just-in-time” cleanups before an inspector arrives.

This expanded approach builds on the agency’s earlier pilots in India and China and makes clear that unannounced inspections are no longer the exception but increasingly the expectation for foreign sites. Importantly, the FDA has also emphasized that it can take regulatory action against firms that delay, deny, or limit inspections, or refuse entry to investigators.

Implications for Manufacturers and Site Leadership

For companies manufacturing drug substances, drug products, biologics components, sterile packaging, excipients, or providing contract testing for U.S.-bound products, the reality is clear: no advance notice should be expected.

The FDA highlights that U.S. manufacturers are frequently inspected without warning, and global suppliers are now expected to meet the same standard. With thousands of inspections conducted worldwide each year, and with data showing serious deficiencies more commonly identified at foreign sites, the agency’s push for parity signals both a higher likelihood of unannounced visits and deeper scrutiny of systems that cannot be staged, such as:

Data integrity
Staff training
Cross-functional compliance

For site leadership, this shift means that inspection readiness must become part of daily operations, not an exercise triggered by preannounced visits.

Systems like QMS, validation records, and data integrity controls must be consistently audit-ready, while staff at every level, from operators to QA reviewers, should be able to engage confidently with inspectors.

Equally critical is the ability to demonstrate digital compliance and cross-functional alignment. Rapid record retrieval, defensible validation evidence, and seamless collaboration between QA, Regulatory, Pharmacovigilance, and IT will be decisive in avoiding findings.

Best Practices to Stay Always Inspection Ready

1. Conduct periodic gap assessments and mock inspections

Test your systems under real conditions, starting from the reception desk to the shop floor. Simulate live document retrievals, floor walks, and cross-questioning to uncover weak spots before inspectors do.

2. Strengthen your digital QMS and data integrity measures

Ensure single-source-of-truth document control, validated reporting queries, and transparent audit trails. Periodic reviews should be up to date and demonstrate ALCOA+ principles in practice.

3. Maintain robust validation packages

From computerized systems (QMS, LIMS, MES, spreadsheets) to facilities, utilities, processes, and laboratory equipment, organizations should maintain clear, accessible validation evidence. This includes role-based access, backup/restore testing, and complete documentation ready for inspection.

4. Prepare your people, not just your paperwork

Train and coach staff so that SMEs, operators, and supervisors can answer confidently, reference procedures, and demonstrate compliance live without hesitation.

5. Reinforce supplier and contract-lab oversight

Inspectors often follow the paper trail. Quality agreements, audit results, and data transfers should show ongoing control, not one-off compliance.

6. Integrate compliance across divisions

Complaints, adverse events, labeling changes, CAPA, and software updates all connect. Seamless cross-functional visibility ensures no gaps are exposed when inspectors trace issues end-to-end.

Final Thoughts

The bottom line: FDA’s expanded use of unannounced inspections makes clear that compliance cannot be staged.

Facilities that build continuous readiness into their culture, through resilient systems, validated processes, and confident people, will not only withstand regulatory scrutiny but also strengthen their operations every day.

How We Can Help

At QbD Group, we support companies in embedding inspection readiness into their daily operations. From gap assessments and mock audits that highlight weaknesses before inspectors arrive, to digital QMS and data integrity checks that ensure systems remain compliant, we help build a reliable foundation.

Our validation and QA expertise ensures that facilities, utilities, processes, equipment, and software remain under control, while training and coaching programs prepare staff to respond with confidence.

With cross-functional support spanning QA, RA, PV, and IT, we provide the comprehensive partnership needed to stay inspection-ready at all times.

Want to ensure your site is always inspection-ready? Contact us today to discuss how we can support your team.