Atlas

Form 483

Anesta LLC Form 483, 2010-10-22

FDA issued a Form 483 to Anesta LLC on 2010-10-22 with 2 public-safe observations.

483· Form 483 issued2 observations

Anesta LLC · Salt Lake City, United States · Issued October 22, 2010

Overview

  • 2 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.

22 Oct 2010
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Erika V Butler

22 Oct 2010
21 CFR 314.81(b)(1)(ii)

Contamination, chemical or physical change, deterioration

Cited by Erika V Butler

Inspected site

ALAnesta LLCSalt Lake City, United States

Inspection team

EVErika V Butler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

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