Atlas

Form 483

H2O Plus, LLC Form 483, 2014-01-29

FDA issued a Form 483 to H2O Plus, LLC on 2014-01-29 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

H2O Plus, LLC · Chicago, United States · Issued January 29, 2014

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.

29 Jan 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Russell K Riley

29 Jan 2014
21 CFR 211.165(e)

Test methods

Cited by Russell K Riley

29 Jan 2014
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Russell K Riley

Inspected site

HPH2O Plus, LLCChicago, United States

Inspection team

RKRussell K Riley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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