Overview
- 6 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
20 May 2022
21 CFR 117.190(a)
Allergen preventive controls - Implementation records
Cited by Sean P Desbrow, Stephanie Barragan
20 May 2022
21 CFR 117.190(a)
Sanitation preventive controls - Implementation records
Cited by Sean P Desbrow, Stephanie Barragan
20 May 2022
21 CFR 117.190(a)
Allergen preventive controls - Implementation records
Cited by Sean P Desbrow, Stephanie Barragan
20 May 2022
21 CFR 117.190(a)
Sanitation preventive controls - Implementation records
Cited by Sean P Desbrow, Stephanie Barragan
20 May 2022
21 CFR 117.190(a)
Allergen preventive controls - Implementation records
Cited by Sean P Desbrow, Stephanie Barragan
Inspected site
GEGalant Enterprises Inc.San Leandro, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.190(a) | Cited across public-safe Form 483 observations | 6x |
Full 483 report
Get the verbatim text of all 6 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