Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-12-11.
At a glance
Inspections
3
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2023 – 11 Dec 2023 | Medical Devices & Rad Health | Clean | |
| 31 Mar 2015 – 25 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jun 2015
21 CFR 50.27(a)
Consent form not approved/signed/dated
Cited by Marcia A Worley, Jeanne J Thai, Jeanne J Chiu
25 Jun 2015
21 CFR 812.100
Investigator lack of control of investigational devices
Cited by Marcia A Worley, Jeanne J Thai, Jeanne J Chiu
25 Jun 2015
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Marcia A Worley, Jeanne J Thai, Jeanne J Chiu
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.100 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Demetrius K. Lopes, M.D.'s 1 Form 483
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat