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 lower risk (patient/user) 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 regulated companies) for clients (new and established clients) over the past several years (since 2022) 100% remotely / virtually, with excellent results. One of these JELALLC virtual audits was to resolve a 483 from the FDA (for the company having done no internal/self audits) on a recently concluded site inspection, for which the FDA found our 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 by the company to the auditor (prior or during);
• Client provides some one proficient with a camera (or phone camera) for site tour videos / 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 7283.850 (Devices, 2026) or FDA Inspection Manuals 7356.002 or-F (Pharma, General / Q10,2022, or -F, APIs, Q7, 2015) 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 principals 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 (usually an e-mail or text 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). 

Note:  While an FDA virtual inspection may follow a similar plant/format, including giving a company an idea of it's concerns after each day's inspection and providing the company a chance to correct (however the 483 observation remains, tho' the comment is added that it was corrected prior to completion of the inspection) and their timing may vary somewhat; the above done by JELALLC adds a client review/comment of the draft, with some possible revisions, and the same with the Final Report.  Such reviews can clear up misunderstandings so they don't remain in the final report, but they do not remove any valid findings, tho' some company explanation may be added.

-  jel@jelincoln.com    04/30 - 05/02/2026,; some clarification added after initial 4/30 publication.