Form 483

Capt'n Chucky's Crab Cake Company, LLC Form 483, 2016-05-10

FDA issued a Form 483 to Capt'n Chucky's Crab Cake Company, LLC on 2016-05-10 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Capt'n Chucky's Crab Cake Company, LLC · Newtown Square, United States · Issued May 10, 2016

Overview

  • 8 public-safe observations are available for this inspection.
  • 7 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.

10 May 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Kyle S Hobson, Sean D Duke

10 May 2016
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Kyle S Hobson, Sean D Duke

10 May 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Kyle S Hobson, Sean D Duke

10 May 2016
21 CFR 123.6(b)

HACCP plan location

Cited by Kyle S Hobson, Sean D Duke

10 May 2016
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Kyle S Hobson, Sean D Duke

Inspected site

CCCapt'n Chucky's Crab Cake Company, LLCNewtown Square, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 observations

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