Overview
- 4 public-safe observations are available for this inspection.
- 4 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 2019
21 CFR 117.35(b)(1)
Cleaning and sanitizing substances- safe and adequate
Cited by Clinton V Giustra, Diantha M Bleau, Christopher J Cruciotti
6 May 2019
21 CFR 123.6(c)(2)
Critical control points
Cited by Clinton V Giustra, Diantha M Bleau, Christopher J Cruciotti
6 May 2019
21 CFR 123.6(c)(7)
Records values/observations
Cited by Clinton V Giustra, Diantha M Bleau, Christopher J Cruciotti
6 May 2019
21 CFR 123.6(c)(3)
Critical limits
Cited by Clinton V Giustra, Diantha M Bleau, Christopher J Cruciotti
Inspected site
KSKlenda Seafood, Inc.South Portland, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(7) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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