Atlas

Form 483

Ipswich Shellfish Co., Inc. Form 483, 2010-02-02

FDA issued a Form 483 to Ipswich Shellfish Co., Inc. on 2010-02-02 with 6 public-safe observations.

483· Form 483 issued6 observations

Ipswich Shellfish Co., Inc. · Ipswich, United States · Issued February 2, 2010

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

2 Feb 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by Christine L Williams

2 Feb 2010
21 CFR 123.6(c)(3)

Critical limits

Cited by Christine L Williams

2 Feb 2010
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Christine L Williams

2 Feb 2010
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Christine L Williams

2 Feb 2010
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Christine L Williams

Inspected site

ISIpswich Shellfish Co., Inc.Ipswich, United States

Inspection team

CLChristine L Williams

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 123.6(c)(3)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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(iii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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