Form 483

Water Pure, Inc. Form 483, 2019-06-26

FDA issued a Form 483 to Water Pure, Inc. on 2019-06-26 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Water Pure, Inc. · Plainview, United States · Issued June 26, 2019

Overview

  • 4 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.

26 Jun 2019
21 CFR 111.55

Production, process controls - implement

Cited by Meredith P Soehl

26 Jun 2019
21 CFR 111.560(a)(2)

Product complaint - quality control investigate

Cited by Meredith P Soehl

26 Jun 2019
21 CFR 111.55

Production, process controls - implement

Cited by Meredith P Soehl

26 Jun 2019
21 CFR 111.560(a)(2)

Product complaint - quality control investigate

Cited by Meredith P Soehl

Inspected site

WPWater Pure, Inc.Plainview, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.55Cited across public-safe Form 483 observations2x
21 CFR 111.560(a)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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