Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Jan 2025
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Jean C Colon Lopez, Othello G Capangpangan, Indigo A Doll
3 Jan 2025
21 CFR 117.135(a)(1)
Allergen preventive controls - Implement
Cited by Jean C Colon Lopez, Othello G Capangpangan, Indigo A Doll
3 Jan 2025
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Jean C Colon Lopez, Othello G Capangpangan, Indigo A Doll
3 Jan 2025
21 CFR 117.410(c)
Supply-chain program - Assurance (Adequate)
Cited by Jean C Colon Lopez, Othello G Capangpangan, Indigo A Doll
3 Jan 2025
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Jean C Colon Lopez, Othello G Capangpangan, Indigo A Doll
Inspected site
GGGate Gourmet, Inc.Seattle, 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 | 1x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.410(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
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 5 observations
The source PDF, 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