Form 483

Anesta LLC Form 483, 2017-03-03

FDA issued a Form 483 to Anesta LLC on 2017-03-03 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Anesta LLC · Salt Lake City, United States · Issued March 3, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

3 Mar 2017
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Tenzin Jangchup, Haroon Vohra, Zachery L Miller

3 Mar 2017
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Tenzin Jangchup, Haroon Vohra, Zachery L Miller

Inspected site

ALAnesta LLCSalt Lake City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x

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