21 CFR 812.43
No investigator agreement
- Inspections citing it: 77
- Of those classified, ended OAI: 42%
- Last cited: FY2025
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Paragraphs Cited
As FDA posts them, all years.
- 812.43(c)
- 21 · No investigator agreement
- 812.43(c)(5)
- 20 · No financial disclosure info in investigator agreement
- 812.43(c)(4)(i)
- 10 · No investigation agreement statement of commitment
- 812.43(a)
- 7 · Investigator(s) not qualified
- 812.43(b)
- 7 · Sponsor shipped devices to unqualified person(s)
- 812.43(d)
- 7 · Monitors not qualified
- 812.43(c)(1)
- 5 · No curriculum vitae in investigator agreement
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Nanospectra Bioscience IncUnited States · Nov 22, 2024
- TriReme Medical, LLC.United States · Oct 30, 2019
- Kennedy, Philip R.United States · Oct 16, 2019
- Vivek Reddy, M.D.United States · Mar 7, 2019
- CAO Group, Inc.United States · May 7, 2018
- Moximed, Inc.United States · Jul 7, 2017
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR