Atlas

Form 483

Charleston Distilling Co. LLC Form 483, 2018-07-20

FDA issued a Form 483 to Charleston Distilling Co. LLC on 2018-07-20 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Charleston Distilling Co. LLC · Johns Island, United States · Issued July 20, 2018

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.

20 Jul 2018
21 CFR 110.20(b)(1)

Sufficient space

Cited by Myckie M Jacobsen

20 Jul 2018
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Myckie M Jacobsen

20 Jul 2018
21 CFR 110.35(e)

Storage of cleaned portable equipment (S)

Cited by Myckie M Jacobsen

Inspected site

CDCharleston Distilling Co. LLCJohns Island, United States

Inspection team

MMMyckie M Jacobsen

Cited regulations

CFR citations associated with this Form 483.

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