Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
19 Feb 2010
21 CFR 111.560(c)
Product complaint - review, investigation
Cited by Rebecca E Dombrowski, Tracey L Siebesma, Caroline H Le, Art O Czabaniuk
Inspected site
LELiving Essentials LLCFarmington Hills, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 483 report
Get the verbatim text of all 10 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere