Atlas

Form 483

Ipswich Shellfish Co., Inc. Form 483, 2019-12-10

FDA issued a Form 483 to Ipswich Shellfish Co., Inc. on 2019-12-10 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Ipswich Shellfish Co., Inc. · Ipswich, United States · Issued December 10, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

10 Dec 2019
21 CFR 123.11(b)

Sanitation monitoring

Cited by Emily J Schramm, Sean M Tessicini, Michael E Antaya

Inspected site

ISIpswich Shellfish Co., Inc.Ipswich, United States

Inspection team

EJEmily J Schramm
SMSean M Tessicini
MEMichael E Antaya

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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