Atlas

Form 483

Ipswich Shellfish Co., Inc. Form 483, 2016-06-09

FDA issued a Form 483 to Ipswich Shellfish Co., Inc. on 2016-06-09 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Ipswich Shellfish Co., Inc. · Ipswich, United States · Issued June 9, 2016

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.

9 Jun 2016
21 CFR 123.11(b)

Sanitation monitoring

Cited by Rupa Pradhan

9 Jun 2016
21 CFR 123.12(a)(2)

Importer verification

Cited by Rupa Pradhan

9 Jun 2016
21 CFR 123.6(c)(3)

Critical limits

Cited by Rupa Pradhan

9 Jun 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Rupa Pradhan

Inspected site

ISIpswich Shellfish Co., Inc.Ipswich, United States

Inspection team

RPRupa Pradhan

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 123.12(a)(2)Cited across public-safe Form 483 observations1x
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

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