Overview
- 22 public-safe observations are available for this inspection.
- 20 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Aug 2010
21 CFR 111.8
Written procedures - hygienic practices
Cited by Kimberly Dutzek, Melanie L Drayton
12 Aug 2010
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by Kimberly Dutzek, Melanie L Drayton
12 Aug 2010
21 CFR 111.12(b)
Personnel - quality control operations; responsibilities
Cited by Kimberly Dutzek, Melanie L Drayton
12 Aug 2010
21 CFR 111.20(b)
Physical plant - space; equipment, materials
Cited by Kimberly Dutzek, Melanie L Drayton
Inspected site
NCNutritional Counselors Of AmericaSpencer, United States
Inspection team
MLMelanie L Drayton
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.10(b)(1) | 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 111.155(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.8 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 22 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