Overview
- 9 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Aug 2011
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Courtney R Bolton, Nicole Yuen, Ingrid A Zambrana, Cynthia L Mccommis
2 Aug 2011
21 CFR 110.20(b)(4)
Drip and condensate
Cited by Courtney R Bolton, Nicole Yuen, Ingrid A Zambrana, Cynthia L Mccommis
2 Aug 2011
21 CFR 110.35(a)
Buildings/good repair
Cited by Courtney R Bolton, Nicole Yuen, Ingrid A Zambrana, Cynthia L Mccommis
2 Aug 2011
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Courtney R Bolton, Nicole Yuen, Ingrid A Zambrana, Cynthia L Mccommis
2 Aug 2011
21 CFR 110.37(b)(5)
Backflow prevention
Cited by Courtney R Bolton, Nicole Yuen, Ingrid A Zambrana, Cynthia L Mccommis
Inspected site
OLOrganicgirl LLCSalinas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(9) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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