Form 483

Sea Fex, Inc. dba Seafood Express Form 483, 2014-03-31

FDA issued a Form 483 to Sea Fex, Inc. dba Seafood Express on 2014-03-31 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Sea Fex, Inc. dba Seafood Express · Telford, United States · Issued March 31, 2014

Overview

  • 8 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.

31 Mar 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by Daniel W Johnson, Brian D Young, Matthew R Noonan, Nancy M Lazzari

31 Mar 2014
21 CFR 123.6(b)

No HACCP plan

Cited by Daniel W Johnson, Brian D Young, Matthew R Noonan, Nancy M Lazzari

31 Mar 2014
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Daniel W Johnson, Brian D Young, Matthew R Noonan, Nancy M Lazzari

31 Mar 2014
21 CFR 123.6(c)(2)

Critical control points

Cited by Daniel W Johnson, Brian D Young, Matthew R Noonan, Nancy M Lazzari

31 Mar 2014
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Daniel W Johnson, Brian D Young, Matthew R Noonan, Nancy M Lazzari

Inspected site

SFSea Fex, Inc. dba Seafood ExpressTelford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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