Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
23 Sep 2021
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Rashonda N Rucker, Alexis S Roberts
23 Sep 2021
21 CFR 117.415(a)(2)
Supply-Chain Appropriate Verification Activities
Cited by Rashonda N Rucker, Alexis S Roberts
23 Sep 2021
21 CFR 120.8(b)(3)
HACCP plan - critical limits not listed or not adequate
Cited by Rashonda N Rucker, Alexis S Roberts
23 Sep 2021
21 CFR 120.8(b)(4)
HACCP plan - monitoring procedures not adequate
Cited by Rashonda N Rucker, Alexis S Roberts
Inspected site
AGArden's GardenEast Point, 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 117.415(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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