Form 483

Earth & Sea Fish Market Inc. Form 483, 2009-12-15

FDA issued a Form 483 to Earth & Sea Fish Market Inc. on 2009-12-15 with 3 public-safe observations.

483· Form 483 issued3 observations

Earth & Sea Fish Market Inc. · Manchester Center, United States · Issued December 15, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

15 Dec 2009
21 CFR 123.6(c)(2)

Monitoring - none

Cited by Joseph T Frost, Brandy L Couillard

15 Dec 2009
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Joseph T Frost, Brandy L Couillard

15 Dec 2009
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Joseph T Frost, Brandy L Couillard

Inspected site

E&Earth & Sea Fish Market Inc.Manchester Center, United States

Inspection team

BLBrandy L Couillard

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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