Atlas

Form 483

Southern Maryland Candy & Tobacco Form 483, 2016-07-20

FDA issued a Form 483 to Southern Maryland Candy & Tobacco on 2016-07-20 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Southern Maryland Candy & Tobacco · La Plata, United States · Issued July 20, 2016

Overview

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

20 Jul 2016
21 CFR 110.20(a)(1)

Harborage areas

Cited by Nina D Patel, Shelby W Brown

20 Jul 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Nina D Patel, Shelby W Brown

20 Jul 2016
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Nina D Patel, Shelby W Brown

Inspected site

SMSouthern Maryland Candy & TobaccoLa Plata, United States

Inspection team

NDNina D Patel
SWShelby W Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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