Form 483

Cape Seafood LLC Form 483, 2019-09-05

FDA issued a Form 483 to Cape Seafood LLC on 2019-09-05 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Cape Seafood LLC · Saco, United States · Issued September 5, 2019

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.

5 Sep 2019
21 CFR 123.6(c)(3)

Critical limits

Cited by Nichole B Murphy, Osama A Khatib, Sean M Tessicini

5 Sep 2019
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Nichole B Murphy, Osama A Khatib, Sean M Tessicini

5 Sep 2019
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Nichole B Murphy, Osama A Khatib, Sean M Tessicini

Inspected site

CSCape Seafood LLCSaco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)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