Form 483

QualiTech, LLC Form 483, 2015-03-30

FDA issued a Form 483 to QualiTech, LLC on 2015-03-30 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

QualiTech, LLC · Chaska, United States · Issued March 30, 2015

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.

30 Mar 2015
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Edward A Fabiano

Inspected site

QLQualiTech, LLCChaska, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

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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