Form 483

Hawaiian Fresh Seafood, Inc. Form 483, 2015-07-31

FDA issued a Form 483 to Hawaiian Fresh Seafood, Inc. on 2015-07-31 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Hawaiian Fresh Seafood, Inc. · San Diego, United States · Issued July 31, 2015

Overview

  • 10 public-safe observations are available for this inspection.
  • 8 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.

31 Jul 2015
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Nicholas L Hunt, Sara J Dent Acosta, Richard B Mcaroy

31 Jul 2015
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Nicholas L Hunt, Sara J Dent Acosta, Richard B Mcaroy

31 Jul 2015
21 CFR 123.11(b)

Sanitation monitoring

Cited by Nicholas L Hunt, Sara J Dent Acosta, Richard B Mcaroy

31 Jul 2015
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Nicholas L Hunt, Sara J Dent Acosta, Richard B Mcaroy

31 Jul 2015
21 CFR 123.6(b)

No HACCP plan

Cited by Nicholas L Hunt, Sara J Dent Acosta, Richard B Mcaroy

Inspected site

HFHawaiian Fresh Seafood, Inc.San Diego, United States

Inspection team

RBRichard B Mcaroy

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 123.11(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(b)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)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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