FDA's Remote Compliance Inspections/Audits:

What originally appeared to be a temporary arrangement to adjust to the Covid 19 shutdown of 2020-2023 - remote / virtual inspections, now appears to be a regular feature used by the FDA remotely / virtually as needed to accomplish some CGMP compliance and other type inspections previously done in-person, on-site.

J. E. Lincoln and Associates LLC has performed several such internal audits (an annual requirement) for clients (new and established clients) over the past several years (since 2022) 100% remotely / virtually, with excellent results. One of these was to resolve a 483 from the FDA on a recently concluded site inspection, for which they found the remediation method acceptable. 

Some considerations:

• An Audit Plan, developed by the auditor, addressing how some areas will be addressed remotely; a brief follow-up phone or e-mail discussion of the Plan and the development of a simplified flow plan / floor plan of the audit site /company by the auditor (approximately 1 week in advance);  
• Pre-submissions of some key documentation (prior or during);
• Client provides some one proficient with a camera (or phone camera) for site pictures, document close-ups, and similar;
• Prearranged Zoom, Teams, or similar meeting (by the auditor, the Audit Meeting), starting with the meeting with the company team, a discussion of the Plan / Schedule / Audit Questionnaire / Matrix based on the applicable CGMPs / Regulations / Standards / FDA Inspection Manual Check List (the day (1-2) of the audit, for usually 2 hours, +/-); 
• A "tour" of the facility (included in the above time frame)
• Q&A (the "meat of the audit") by the auditor using the Inspection Check List, verified by photos, videos, submissions as needed to resolve questionable areas / documentation / records (part of the above, any additional time to resolve any serious issues);
• Break.  Auditor drafts preliminary report based on the Questionnaire  (usually 1 - 2 hours);
• Resume Virtual Meeting with QA/Company principles to review the Draft report (usually 1 hour or less);
• Resolve any disagreements and develop remediation plan / responses as needed (included in above or a separate series of communications;
• Draft Final Report and submit for review and discussion (about one+ weeks later);
• Submit Final Report, in agreed electronic format as well as a written Report by mail (usually 1-2 days after final draft review). 

The above is for a small or medium-sized company, with the actual audit taking portions of one to two days.

Note:  Per the new FDA Device Inspection Manual, Feb 02, 2026 (and 21 CFR 820 / QMSR Final Rule Preamble), company internal audits, vendor audits, and similar, are no longer "off limits" to an FDA inspector / inspection). 

-  jel@jelincoln.com    04/30/2026