Form 483

Tropic Star Seafood, Inc. Form 483, 2011-07-21

FDA issued a Form 483 to Tropic Star Seafood, Inc. on 2011-07-21 with 5 public-safe observations.

483· Form 483 issued5 observations

Tropic Star Seafood, Inc. · Lakeland, United States · Issued July 21, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

21 Jul 2011
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Jason D Tenney, Jessica L Pressley, Nelson E Venerio

21 Jul 2011
21 CFR 123.6(b)

HACCP plan implementation

Cited by Jason D Tenney, Jessica L Pressley, Nelson E Venerio

21 Jul 2011
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Jason D Tenney, Jessica L Pressley, Nelson E Venerio

21 Jul 2011
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Jason D Tenney, Jessica L Pressley, Nelson E Venerio

21 Jul 2011
21 CFR 123.11(b)

Sanitation monitoring

Cited by Jason D Tenney, Jessica L Pressley, Nelson E Venerio

Inspected site

TSTropic Star Seafood, Inc.Lakeland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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