Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
28 Oct 2022
21 CFR 117.35(a)
Sanitary operations - Plant sanitation
Cited by Angela F Orozco, Brian M Carril
28 Oct 2022
21 CFR 117.35(b)(2)
Toxic chemicals - Identified, held, stored
Cited by Angela F Orozco, Brian M Carril
28 Oct 2022
21 CFR 117.35(d)
Sanitation of food-contact surfaces - Frequency
Cited by Angela F Orozco, Brian M Carril
Inspected site
DEDalex Enterprises Inc. dba Cruz BakeryHialeah, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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