Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
9 Aug 2019
21 CFR 123.11(b)
Sanitation monitoring
Cited by Hugh Grimoldby, Julia E Chervoni, David J Gomes, Rocco C Black
9 Aug 2019
21 CFR 123.6(b)
HACCP plan implementation
Cited by Hugh Grimoldby, Julia E Chervoni, David J Gomes, Rocco C Black
9 Aug 2019
21 CFR 123.6(c)(2)
Critical control points
Cited by Hugh Grimoldby, Julia E Chervoni, David J Gomes, Rocco C Black
9 Aug 2019
21 CFR 123.6(c)(4)
Monitoring - adequacy
Cited by Hugh Grimoldby, Julia E Chervoni, David J Gomes, Rocco C Black
9 Aug 2019
21 CFR 123.6(d)
Signed and dated
Cited by Hugh Grimoldby, Julia E Chervoni, David J Gomes, Rocco C Black
Inspected site
BFBenthic Fishing, LLCSumner, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | 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)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | 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