Atlas

Form 483

North American Science Associates, LLC Form 483, 2010-09-24

FDA issued a Form 483 to North American Science Associates, LLC on 2010-09-24 with 2 public-safe observations.

483· Form 483 issued2 observations

North American Science Associates, LLC · Irvine, United States · Issued September 24, 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.

24 Sep 2010
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Joey V Quitania

24 Sep 2010
21 CFR 211.192

No written record of investigation

Cited by Joey V Quitania

Inspected site

NANorth American Science Associates, LLCIrvine, United States

Inspection team

JVJoey V Quitania

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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