Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
13 Dec 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Sondra L Phillips, Simone E Hollis
13 Dec 2018
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Sondra L Phillips, Simone E Hollis
13 Dec 2018
21 CFR 111.510
Returned dietary supplement - material review, disposition
Cited by Sondra L Phillips, Simone E Hollis
13 Dec 2018
21 CFR 111.75(c)(2)
Specifications met - test, examinations; compliance
Cited by Sondra L Phillips, Simone E Hollis
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 111.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.510 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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