Overview
- 18 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-26.
At a glance
Inspections
18
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Apr 2022 – 26 Apr 2022 | Human Drugs | Clean | |
| 7 Sep 2021 – 8 Sep 2021 | Human Drugs | Clean | |
| 28 May 2019 – 30 May 2019 | Human Drugs | Clean | |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | 483 | View 483 → |
| 20 Aug 2018 – 23 Aug 2018 | Human Drugs | Clean | |
| 13 Nov 2017 – 16 Nov 2017 | Human Drugs | Clean | |
| 25 Apr 2016 – 3 May 2016 | Human Drugs | Clean | |
| 16 Apr 2014 – 23 Apr 2014 | Human Drugs | 483 | View 483 → |
| 5 Aug 2011 | Not recorded | Clean | |
| 20 Jan 2011 | Not recorded | Clean | |
| 12 Nov 2010 | Not recorded | Clean | |
| 29 Sep 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Johnetta F Walters, Tamara J Henderson
23 Apr 2014
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Johnetta F Walters, Tamara J Henderson
23 Apr 2014
21 CFR 211.192
Written record of investigation incomplete
Cited by Johnetta F Walters, Tamara J Henderson
Investigators
FDA investigators tied to this site in the record.
Gabriel R Mclemore3 insp.
Veronica Fuentes2 insp.
Vanessa E Coulter2 insp.
Tamara J Henderson2 insp.
Johnetta F Walters2 insp.
Hai Lien T Phung2 insp.
Jamirya S Weatherly1 insp.
Carol F Robinson1 insp.
Rachael L Cook1 insp.
Steven J Rush1 insp.
Marcia Gelber1 insp.
Gideon N Esuzor1 insp.
Jason F Chancey1 insp.
Joseph F Owens1 insp.
Thomas R Berry1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mikart, LLC'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