Atlas

Form 483

Maine Lobster Outlet, LLC Form 483, 2010-09-07

FDA issued a Form 483 to Maine Lobster Outlet, LLC on 2010-09-07 with 3 public-safe observations.

483· Form 483 issued3 observations

Maine Lobster Outlet, LLC · Kittery, United States · Issued September 7, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

7 Sep 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Kathleen E Mcafoose

7 Sep 2010
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Kathleen E Mcafoose

7 Sep 2010
21 CFR 123.8(a)(2)

Ongoing verification - complaints, calibration records

Cited by Kathleen E Mcafoose

Inspected site

MLMaine Lobster Outlet, LLCKittery, United States

Inspection team

KEKathleen E Mcafoose

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)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