Overview
- 8 public-safe observations are available for this inspection.
- 7 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.
6 May 2021
21 CFR 123.11(b)
Sanitation monitoring
Cited by Aaron F Coleman, Stacey L Witherwax, Brian M Carril
6 May 2021
21 CFR 123.11(c)
Sanitation Records
Cited by Aaron F Coleman, Stacey L Witherwax, Brian M Carril
6 May 2021
21 CFR 123.12(a)(2)
Importer verification
Cited by Aaron F Coleman, Stacey L Witherwax, Brian M Carril
6 May 2021
21 CFR 123.6(b)
HACCP plan implementation
Cited by Aaron F Coleman, Stacey L Witherwax, Brian M Carril
Inspected site
OROcho Rios-Miami, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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