Atlas

Form 483

Dowser, LLC Form 483, 2019-07-30

FDA issued a Form 483 to Dowser, LLC on 2019-07-30 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Dowser, LLC · Newburgh, United States · Issued July 30, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

30 Jul 2019
21 CFR 129.20(a)

Bottling room separation, plant operations

Cited by Christopher S Fields

30 Jul 2019
21 CFR 129.80(c)

Records - cleaning, sanitizing solutions

Cited by Christopher S Fields

Inspected site

DLDowser, LLCNewburgh, United States

Inspection team

CSChristopher S Fields

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 129.20(a)Cited across public-safe Form 483 observations1x
21 CFR 129.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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