Overview
- 6 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.
16 Aug 2019
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Carrie E Jolly, Mahlet Goitom
16 Aug 2019
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Carrie E Jolly, Mahlet Goitom
16 Aug 2019
21 CFR 111.75(f)(2)
Label - visual examination, review supplier's documentation
Cited by Carrie E Jolly, Mahlet Goitom
16 Aug 2019
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Carrie E Jolly, Mahlet Goitom
16 Aug 2019
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Carrie E Jolly, Mahlet Goitom
Inspected site
ELEyeFive, LLCEnglewood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(f)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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