Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-10.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2022 – 10 Jun 2022 | Human Drugs | 483 | View 483 → |
| 8 Aug 2017 – 15 Aug 2017 | Human Drugs | 483 | View 483 → |
| 15 Feb 2012 | Not recorded | Clean | |
| 14 Nov 2011 | Not recorded | Clean | |
| 6 Dec 2010 | Not recorded | 483 | View 483 → |
| 4 Aug 2010 | Not recorded | Clean | |
| 8 Jul 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jun 2022
21 CFR 211.186(a)
Master production and control records, procedure
Cited by Steven P Eastham, Lisa R Hilliard, Wen Ning Chan
10 Jun 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Steven P Eastham, Lisa R Hilliard, Wen Ning Chan
15 Aug 2017
21 CFR 211.122(d)
Labels and labeling stored separately
Cited by Heather A Mccauley, Kenneth E Felkley
6 Dec 2010
21 CFR 211.94(a)
Reactive/Additive/Absorptive Containers/Closures
Cited by Nadeem I Chaudhry
Investigators
FDA investigators tied to this site in the record.
Nadeem I Chaudhry3 insp.
Steven P Eastham1 insp.
Lisa R Hilliard1 insp.
Wen Ning Chan1 insp.
Heather A Mccauley1 insp.
Kenneth E Felkley1 insp.
Teresa K Kastner1 insp.
Jennifer L Gustavus1 insp.
Joshua S Hunt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ellis Family Holdings, LLC's 4 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