Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-07-25.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jul 2013 – 25 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
| 3 Dec 2010 | Not recorded | Clean | |
| 19 Feb 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Feb 2010
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by Rebecca E Dombrowski, Tracey L Siebesma, Caroline H Le, Art O Czabaniuk
19 Feb 2010
21 CFR 111.12(b)
Personnel - quality control operations
Cited by Rebecca E Dombrowski, Tracey L Siebesma, Caroline H Le, Art O Czabaniuk
19 Feb 2010
21 CFR 111.14(b)(2)
Personnel - records - training
Cited by Rebecca E Dombrowski, Tracey L Siebesma, Caroline H Le, Art O Czabaniuk
19 Feb 2010
21 CFR 111.553
Written procedures - product complaint
Cited by Rebecca E Dombrowski, Tracey L Siebesma, Caroline H Le, Art O Czabaniuk
Investigators
FDA investigators tied to this site in the record.
Michele L Forster1 insp.
Jeffrey D Meng1 insp.
Rebecca E Dombrowski1 insp.
Tracey L Siebesma1 insp.
Caroline H Le1 insp.
Art O Czabaniuk1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(2)(ii)(F) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Living Essentials LLC's 2 Form 483s
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