Overview
- 21 public-safe observations are available for this inspection.
- 21 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.
4 Feb 2013
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Sandra I Gaul, Ana L Kewes
4 Feb 2013
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Sandra I Gaul, Ana L Kewes
Inspected site
ENEvol Nutrition Associates, Inc.Marietta, United States
Inspection team
ALAna L Kewes
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.117 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(a)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.375(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 21 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