Form 483

Hawaiian Fresh Seafood, Inc. Form 483, 2013-08-16

FDA issued a Form 483 to Hawaiian Fresh Seafood, Inc. on 2013-08-16 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Hawaiian Fresh Seafood, Inc. · San Diego, United States · Issued August 16, 2013

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

16 Aug 2013
21 CFR 123.6(c)(2)

Critical control points

Cited by Sara J Dent Acosta

16 Aug 2013
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Sara J Dent Acosta

16 Aug 2013
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Sara J Dent Acosta

16 Aug 2013
21 CFR 123.9(a)

Records - content

Cited by Sara J Dent Acosta

16 Aug 2013
21 CFR 123.11(b)

Sanitation monitoring

Cited by Sara J Dent Acosta

Inspected site

HFHawaiian Fresh Seafood, Inc.San Diego, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)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