Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
28 Apr 2026
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Sharon Giamberini, Yazmith Guzman, Brian M Carril
28 Apr 2026
21 CFR 117.135(a)(1)
Process preventive controls - Implement
Cited by Sharon Giamberini, Yazmith Guzman, Brian M Carril
Inspected site
DEDalex Enterprises IncHialeah, 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 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 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