Form 483

Monterey Fish Company, Inc. Form 483, 2013-07-30

FDA issued a Form 483 to Monterey Fish Company, Inc. on 2013-07-30 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Monterey Fish Company, Inc. · Monterey, United States · Issued July 30, 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.

30 Jul 2013
21 CFR 123.6(b)

HACCP plan implementation

Cited by Wayne L Jefferson

30 Jul 2013
21 CFR 123.6(c)(7)

Records system

Cited by Wayne L Jefferson

30 Jul 2013
21 CFR 123.6(d)

Signed and dated

Cited by Wayne L Jefferson

30 Jul 2013
21 CFR 123.8(a)(2)

Ongoing verification - complaints, calibration records

Cited by Wayne L Jefferson

30 Jul 2013
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Wayne L Jefferson

Inspected site

MFMonterey Fish Company, Inc.Monterey, 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(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)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