Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-26.
At a glance
Inspections
5
Form 483s
4
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2023 – 26 May 2023 | Animal Drugs & Feeds | 483 | View 483 → |
| 18 Mar 2019 – 21 Mar 2019 | Animal Drugs & Feeds | 483 | On file |
| 26 May 2016 – 8 Jun 2016 | Animal Drugs & Feeds | Clean | |
| 9 Oct 2014 – 21 Oct 2014 | Animal Drugs & Feeds | 483 | On file |
| 29 May 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2023
21 CFR 58.35(b)(7)
QAU: signed statement in final report
Cited by Ann B Borromeo, Kellie R Riggs
Investigators
FDA investigators tied to this site in the record.
Ann B Borromeo5 insp.
Kellie R Riggs1 insp.
Delisa R Davis1 insp.
Ana C Lazo1 insp.
Daniel L Aisen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.35(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind East Tennessee Clinical Research, Inc's 4 Form 483s
Source PDFs 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