Overview
- 7 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.
16 Mar 2016
21 CFR 120.11(a)(1)(iv)
Verification - CCP, CA record review
Cited by Nympha V Florendo, Emal Wahab, Maridali De Leon-Torres
16 Mar 2016
21 CFR 120.12(c)
Records - signed/dated
Cited by Nympha V Florendo, Emal Wahab, Maridali De Leon-Torres
16 Mar 2016
21 CFR 120.8(b)(2)
HACCP plan - critical control points not listed
Cited by Nympha V Florendo, Emal Wahab, Maridali De Leon-Torres
16 Mar 2016
21 CFR 120.8(b)(3)
HACCP plan - critical limits not listed or not adequate
Cited by Nympha V Florendo, Emal Wahab, Maridali De Leon-Torres
16 Mar 2016
21 CFR 120.8(b)(5)
HACCP plan - corrective action plan not included
Cited by Nympha V Florendo, Emal Wahab, Maridali De Leon-Torres
Inspected site
RRRatzlaff Ranch Inc.Sebastopol, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 120.11(a)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.7(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(5) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
Every observation in full, 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