Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-30.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2024 – 30 Oct 2024 | Biologics | 483 | View 483 → |
| 13 Jan 2020 – 15 Jan 2020 | Biologics | 483 | View 483 → |
| 8 Jan 2018 – 10 Jan 2018 | Biologics | Clean | |
| 19 Jan 2016 – 21 Jan 2016 | Biologics | Clean | |
| 12 Jun 2014 – 13 Jun 2014 | Biologics | Clean | |
| 16 Feb 2012 | Not recorded | Clean | |
| 16 Apr 2010 | Not recorded | 483 | View 483 → |
| 26 Jun 2008 | Not recorded | Clean | |
| 13 Jul 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Oct 2024
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Kenneth L Smalls, Danielle R Rainey
30 Oct 2024
21 CFR 606.151(e)
Procedures to maintain records of emergency transfusions
Cited by Kenneth L Smalls, Danielle R Rainey
16 Apr 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Hristu B Chepa
Investigators
FDA investigators tied to this site in the record.
Brian A Graves2 insp.
Dellarese L Herbert2 insp.
Kenneth L Smalls1 insp.
Danielle R Rainey1 insp.
Ernest H Blackwood1 insp.
Hristu B Chepa1 insp.
Cordelia J Brammer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.151(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lexington Medical Center's 3 Form 483s
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