Atlas

Form 483

Heller's Seafood Market, Inc. Form 483, 2014-08-07

FDA issued a Form 483 to Heller's Seafood Market, Inc. on 2014-08-07 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Heller's Seafood Market, Inc. · Warrington, United States · Issued August 7, 2014

Overview

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

Inspectional observations

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

7 Aug 2014
21 CFR 123.8(a)(2)

Ongoing verification - complaints, calibration records

Cited by James P Mcevoy, Sharon Mills, Nancy M Lazzari

7 Aug 2014
21 CFR 123.8(d)

Verification - recordkeeping

Cited by James P Mcevoy, Sharon Mills, Nancy M Lazzari

7 Aug 2014
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by James P Mcevoy, Sharon Mills, Nancy M Lazzari

Inspected site

HSHeller's Seafood Market, Inc.Warrington, United States

Inspection team

JPJames P Mcevoy
SMSharon Mills
NMNancy M Lazzari

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 123.8(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.8(d)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