Alternative Inspection Methods of the FDA

In a news dated 24 September 2025, we referred to an FDA guideline on 'remote oversight tools'. The exact title is 'Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications'. It presents alternatives to on-site inspections in the context of marketing applications. Below is an analysis.

With 11 pages the guidance is not very long and is easy to read. The aim is to provide applicants for approval (NDA, ANDA, BLA) with information on alternative methods to an on-site inspection by the FDA. This is based on experience gained during the coronavirus pandemic. The guidance does not apply to the following types of inspection:

• Post-approval inspections
• Surveillance inspections without pre-approval or pre-licence components#
• Compliance inspections (e.g.for-cause inspections)
• Bioresearch monitoring inspections

The guideline then mentions inspection methods that have proven effective during the coronavirus pandemic for pre-approval and pre-licence inspections based on a risk assessment:

• Requesting reports and other information directly from the company or unit to be inspected 
• Remote access (remote interactive evaluation, RIE, or remote regulatory assessment, RRA), such as live stream videos of on-site activities, telephone conferences, screen sharing
• Requesting current inspection reports and other information from trusted authorities under a Mutual Recognition Agreement (MRA).

Interestingly, the guideline also mentions hybrid inspections, although the term is not used. It also describes the possibility of an on-site inspection by a third-party authority with FDA support via remote access. The FDA has created a new function for remote access: an FDA remote subject matter expert.

The use of alternative methods will be determined on a risk-based basis. Factors to be considered include product-related risks, the manufacturing process and risks posed by the manufacturing facility itself. Specifically mentioned are:

• current scientific knowledge
• New manufacturing technologies
• New dosage forms
• Complexity of the manufacturing process
• Little manufacturing experience on a commercial scale
• Problems from previous FDA inspections or with other external authorities

Positive aspects of using alternative methods include:

• A good FDA inspection history and/or one from an MRA partner authority and the same or similar production processes in the application for approval compared to existing products
• The specific risks arising from the approval or due to the activities that exist in the company and that can also be assessed with the alternative tools
• The product is urgently needed
• An on-site inspection is not possible due to travel restrictions (pandemics, natural disasters).

Following, further details on the individual alternative methods mentioned above can be found. Explicit reference is made to the Guidance for Industry on 'Conduction Remote Regulatory Assessments: Questions and Answers' (June 2025). The guidance also mentions that the FDA will not take any recordings during remote access. Interestingly, when alternative methods are used, no 483 forms will be issued, but simply a list of deficiencies.

Conclusion: As a result of the experience gained during the coronavirus pandemic, the FDA considers alternative options to on-site inspections as a possibility in the context of marketing authorisation applications.

You can find the guidance document 'Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications' on the FDA website.