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.
10 Oct 2014
21 CFR 123.6(c)(4)
Monitoring - adequacy
Cited by Anastasia M Shields, Matthew R Noonan, Sharon Mills
10 Oct 2014
21 CFR 123.6(c)(5)
Corrective action plan
Cited by Anastasia M Shields, Matthew R Noonan, Sharon Mills
10 Oct 2014
21 CFR 123.6(c)(6)
Verification procedures - adequacy
Cited by Anastasia M Shields, Matthew R Noonan, Sharon Mills
10 Oct 2014
21 CFR 123.6(c)(7)
Records system
Cited by Anastasia M Shields, Matthew R Noonan, Sharon Mills
Inspected site
SFSea Fex, Inc. dba Seafood ExpressTelford, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.6(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(5) | 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(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