Atlas

Form 483

Nelson Laboratories, LLC Form 483, 2016-02-26

FDA issued a Form 483 to Nelson Laboratories, LLC on 2016-02-26 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Nelson Laboratories, LLC · Salt Lake City, United States · Issued February 26, 2016

Overview

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

Inspectional observations

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

26 Feb 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jamie L Dion, Marie B Buen-Bigornia

26 Feb 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jamie L Dion, Marie B Buen-Bigornia

26 Feb 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jamie L Dion, Marie B Buen-Bigornia

26 Feb 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jamie L Dion, Marie B Buen-Bigornia

Inspected site

NLNelson Laboratories, LLCSalt Lake City, United States

Inspection team

JLJamie L Dion
MBMarie B Buen-Bigornia

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 4 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