Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Nov 2017
21 CFR 123.6(c)(6)
Verification procedures - adequacy
Cited by Sheila Alaghemand, Edith M Gonzalez, Jessica M Ector, Christine L Williams
17 Nov 2017
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Sheila Alaghemand, Edith M Gonzalez, Jessica M Ector, Christine L Williams
17 Nov 2017
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Sheila Alaghemand, Edith M Gonzalez, Jessica M Ector, Christine L Williams
17 Nov 2017
21 CFR 123.8(b)
Verification - corrective action
Cited by Sheila Alaghemand, Edith M Gonzalez, Jessica M Ector, Christine L Williams
17 Nov 2017
21 CFR 123.6(c)(1)
Food safety hazards
Cited by Sheila Alaghemand, Edith M Gonzalez, Jessica M Ector, Christine L Williams
Inspected site
EFEtai's Food, LLC.Denver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.8(b) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF and 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