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.
12 May 2026
21 CFR 118.4
Written SE plan lacks required elements
Cited by Eva I Merced Medina, Keishla M Arroyo Lopez
12 May 2026
21 CFR 118.4(c)(1)
Monitoring for rodents
Cited by Eva I Merced Medina, Keishla M Arroyo Lopez
12 May 2026
21 CFR 118.4(c)(2)
Satisfactory fly control methods
Cited by Eva I Merced Medina, Keishla M Arroyo Lopez
12 May 2026
21 CFR 118.4(c)(3)
Removal of pest harborages
Cited by Eva I Merced Medina, Keishla M Arroyo Lopez
Inspected site
RGRobert G MillerOrocovis, 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 | 1x |
| 21 CFR 118.4(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(c)(3) | 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