Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Records - equipment cleaning and sanitizing
Cited by Marc Balzarini, David P King, Karl D Hezel, Narahi J Alvarez Alcazar
Sampling plan
Cited by Marc Balzarini, David P King, Karl D Hezel, Narahi J Alvarez Alcazar
Written sampling plan for spent irrigation water or sprouts
Cited by Marc Balzarini, David P King, Karl D Hezel, Narahi J Alvarez Alcazar
Release before negative test results
Cited by Marc Balzarini, David P King, Karl D Hezel, Narahi J Alvarez Alcazar
Hygienic practices
Cited by Marc Balzarini, David P King, Karl D Hezel, Narahi J Alvarez Alcazar
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 112.140(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.145(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.147(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.147(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.32 | 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