What FDA’s expanded use of unannounced foreign inspections means for global manufacturers
The U.S. Food and Drug Administration (FDA) has announced a pivotal shift in its inspection strategy, expanding the use of unannounced and short-notice inspections at foreign drug, biologic, and device manufacturing sites[i]. This policy move reinforces FDA’s commitment to restoring inspectional rigor and enhancing global oversight in the post-pandemic regulatory landscape.
What’s changing?
Historically, inspections at non-US manufacturing facilities were often pre-announced due to diplomatic protocols or logistical constraints. The FDA will now begin expanding unannounced inspections abroad, bringing foreign facilities under the same compliance spotlight as their U.S. counterparts.
The FDA has brought about this change to ensure there is consistent regulatory oversight and certify that the same stance is employed between domestic and foreign facility (non-US) inspections. The FDA anticipates that the unannounced inspections will prevent foreign facilities from concealing violations, preventing fraud and, importantly, keep unsafe products out of the United States. This expanded approach may directly impact the following industries:
- Active pharmaceutical ingredient (API) manufacturers
- Contract development and manufacturing organizations (CDMOs/CMOs)
- Drug manufacturers – medicinal products, biologics and ATMPs
- Research firms and clinical trial facilities
- Distributors
Non-compliance with 21 CFR Parts 210/211 (drugs), 820 (devices), 600 (biologics), or 1271 (human cells, tissues, and cellular and tissue-based products)[ii] may lead to immediate issuance of a Form 483, warning letters, withdrawal of approvals, clinical holds, import alerts, or supply chain restrictions[iii]. To date, as a result of unannounced inspections, there has been an increase in the issuance of Form 483s to foreign facilities. On scrutiny, the following are examples of the top noted non-compliance issues at drug and device manufacturing facilities:
- Lack of or inadequate procedures (circa 4000 citations)
- Lack of or inadequate complaint procedures (circa 3000 citations)
- Procedures not in writing or fully followed (circa 2000 citations)[iv]
Key steps to inspection readiness
To be in a state of readiness for unannounced inspections, facilities need to ensure that site documentation is up to date and reflective of current processes. All documentation needs to be readily available. Regular review of site policies and procedures is key to achieving compliance with current regulations and best practices.
Facilities need to ensure the manufacturing sites and suppliers they engage are inspection-ready for unannounced inspections.
Training site personnel on inspection protocol is paramount. Personnel should know what to expect during an inspection and how to respond. There should be someone from the facility available to address any questions during the inspection, so ensuring that person is trained and able to respond to inspectors is crucial.
Facilities can prepare for inspections by spending time in advance to clearly define roles and responsibilities of personnel during an inspection.
A robust internal auditing program focusing on previous FDA findings that could potentially lead to import alerts, warning letters, and application hold-up or denials would allow facilities to determine how best to implement corrective actions.
Facilities are also advised to routinely monitor site key performance indicators to self-identify potential issues and promptly address findings.
Be proactive, not reactive
FDA’s new policy is not a temporary initiative, it represents a fundamental shift in the regulatory environment. Manufacturers must adopt a culture of continuous compliance and ensure robust, inspection-ready systems are in place regardless of location.
Author:
Louise Uí Fhatharta is a manager/ consultant at Pharmalex Ireland. She is a quality professional with more than 20 years of experience in microbiology, quality control and quality assurance roles in the pharmaceutical industry including sterile fill finish and medical device (including combination products). She has helped companies to successfully navigate several competent authority inspections including but not limited to inspections by FDA, Ireland’s HPRA, and Brazil’s ANVISA.
[i] FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities, FDA, May 2025. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities | FDA
[ii] Title 21, Code of Federal Regulations, National Archives. https://www.ecfr.gov/current/title-21
[iii] Inspection observations, FDA. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
[iv] FDA Inspections dashboard. FDA Dashboards – Inspections
