Form 483

Water-Jel Technologies, LLC Form 483, 2014-10-10

FDA issued a Form 483 to Water-Jel Technologies, LLC on 2014-10-10 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Water-Jel Technologies, LLC · Huntersville, United States · Issued October 10, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Oct 2014
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Helen Verdel

Inspected site

WTWater-Jel Technologies, LLCHuntersville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 1 observation

The source PDF and 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