Form 483

Monarch Seafood Inc. Form 483, 2009-11-03

FDA issued a Form 483 to Monarch Seafood Inc. on 2009-11-03 with 4 public-safe observations.

483· Form 483 issued4 observations

Monarch Seafood Inc. · Roselle, United States · Issued November 3, 2009

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

3 Nov 2009
21 CFR 123.6(b)

HACCP plan implementation

Cited by Laishan L Lam

3 Nov 2009
21 CFR 123.7(d)

Corrective action documentation

Cited by Laishan L Lam

3 Nov 2009
21 CFR 123.8(d)

Verification - recordkeeping

Cited by Laishan L Lam

3 Nov 2009
21 CFR 123.9(a)

Records - content

Cited by Laishan L Lam

Inspected site

MSMonarch Seafood Inc.Roselle, 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 observations1x
21 CFR 123.7(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(d)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 4 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