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.
15 Jul 2022
21 CFR 117.35(b)(2)
Toxic chemicals - Identified, held, stored
Cited by Ninfa N Innocent, Axel M Ambert
15 Jul 2022
21 CFR 117.80(b)(8)
Raw materials - Allergen identification
Cited by Ninfa N Innocent, Axel M Ambert
15 Jul 2022
21 CFR 123.8(a)(3)(i)
Monitoring record review adequacy
Cited by Ninfa N Innocent, Axel M Ambert
Inspected site
EGEl Gordo Spices, LLCDallas, United States
Inspection team
AMAxel M Ambert
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3)(i) | 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