Overview
- 8 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.
7 Mar 2025
21 CFR 118.4
Written SE plan lacks required elements
Cited by Jose Perez-Soto, Katherine Vargas-Serrano
7 Mar 2025
21 CFR 118.4
Written SE plan lacks required elements
Cited by Jose Perez-Soto, Katherine Vargas-Serrano
7 Mar 2025
21 CFR 118.4
Written SE plan not implemented/followed
Cited by Jose Perez-Soto, Katherine Vargas-Serrano
7 Mar 2025
21 CFR 118.4
Written SE plan not implemented/followed
Cited by Jose Perez-Soto, Katherine Vargas-Serrano
7 Mar 2025
21 CFR 118.4(a)(2)(i)
Pullet environment testing
Cited by Jose Perez-Soto, Katherine Vargas-Serrano
Inspected site
GAGranja Avicola Pujols CorpSan Sebastian, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 118.4 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 118.4(a)(2)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 118.5(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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