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# New FDA Rules on Inspection Records Requests
- URL: https://www.fdaweb.com/new-fda-rules-on-inspection-records-requests/
- Published: 2021-02-01T12:00:00.000Z
- Updated: 2026-09-14T16:44:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148561

FDA has set up an interim process to communicate issues identified following a review of records or other information requested prior to or in lieu of a drug/biologic pre-approval/pre-license inspection. During the Covid-19 emergency, manufacturing records are being requested under 704(a)(4) of the Federal Food, Drug, and Cosmetic Act ([see earlier story](https://www.fdaweb.com/fda-exploring-live-video-inspections-during-covid/)).

Under the interim measure, FDA intends to communicate issues to facility representatives following the completion of its review of records or other information requested under section 704(a)(4). “The agency plans to consider any formal responses regarding these issues prior to taking an action on a pending application impacted by these issues, as feasible given user fee agreement and internal review program milestones,” it says. “The interim process will be implemented for the remainder of the COVID-19 public health emergency and evaluated periodically, revised as needed, and may be expanded to record request processes in lieu or in advance of other drug inspection programs (e.g., routine surveillance).

The process has been included in the revised guidance [*Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency Questions and Answers*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTAyMDEuMzQzODIwMzEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvbWFudWZhY3R1cmluZy1zdXBwbHktY2hhaW4tYW5kLWRydWctYW5kLWJpb2xvZ2ljYWwtcHJvZHVjdC1pbnNwZWN0aW9ucy1kdXJpbmctY292aWQtMTktcHVibGljLWhlYWx0aD91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.oyahst1mU1AvLeN8tsIjlofCfvCY8kPrKUJBICLbBi8/s/1255931999/br/96859538648-l?ref=fdaweb.com) (see question 5), and posted to FDA’s Web page, “[Manufacturing, Supply Chain, and Drug Inspections – Covid-19](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTAyMDEuMzQzODIwMzEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L2RydWdzL2Nvcm9uYXZpcnVzLWNvdmlkLTE5LWRydWdzL21hbnVmYWN0dXJpbmctc3VwcGx5LWNoYWluLWFuZC1kcnVnLWluc3BlY3Rpb25zLWNvdmlkLTE5P3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.liF5a-NP3LxbBD%5F2tHpClfucEhA1Ex88jur4tZSwl3s/s/1255931999/br/96859538648-l?ref=fdaweb.com).”

[Late last year](https://www.fdaweb.com/fda-exploring-live-video-inspections-during-covid/), FDA associate commissioner for regulatory affairs **Judith McMeekin** told the Food and Drug Law Institute’s virtual annual conference that the Office of Regulatory Affairs is “exploring the use of a remote regulatory assessment program, and we hope to work with industry to use this approach for programs where the 704(a)(4) records request authority does not explicitly apply. This new approach would involve a remote review of records that a firm is required to maintain for the FDA’s review. The remote review could be used to help determine whether a firm complies with regulatory requirements. In general, the information obtained from such remote review could inform further follow-up by the FDA, and may allow us to focus and limit time needed on an onsite inspection or advance the inspection to a later date.”

Meanwhile, an [*FDALawBlog.com post*](https://www.fdalawblog.net/2021/01/conducting-virtual-inspections-ema-and-mhra-do-it-cmos-do-it-why-wont-fda-do-it/?ref=fdaweb.com) by Hyman, Phelps & McNamara attorney **Douglas Farquhar** questions why FDA is reluctant to use virtual inspections at drug manufacturing facilities, especially considering drug approvals are being blocked due to a missed inspection. Despite its use in food-manufacturing facilities, FDA has not promulgated guidance or publicized policies on virtual drug inspections, he said. “By contrast, the European drug manufacturing regulatory body (the European Medicines Agency, or EMA) and its British counterpart (the Medicines and Healthcare products Regulatory Agency, or MHRA) have been performing such inspections since March.”