Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
30 Jan 2020
21 CFR 111.103
Written procedures - quality control operations
Cited by Juliana Falla, Victoria L Palmer
30 Jan 2020
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Juliana Falla, Victoria L Palmer
30 Jan 2020
21 CFR 111.470
Distribute dietary supplement; contamination, deterioration
Cited by Juliana Falla, Victoria L Palmer
Inspected site
ENEvol Nutrition Associates, Inc.Marietta, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.470 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 observations
The full inspection record, as Atlas holds it, 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