Atlas

Form 483

Neuro-Fitness LLC Form 483, 2010-09-30

FDA issued a Form 483 to Neuro-Fitness LLC on 2010-09-30 with 3 public-safe observations.

483· Form 483 issued3 observations

Neuro-Fitness LLC · Fall City, United States · Issued September 30, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

30 Sep 2010
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Stephen R Souza

30 Sep 2010
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Stephen R Souza

30 Sep 2010
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Stephen R Souza

Inspected site

NLNeuro-Fitness LLCFall City, United States

Inspection team

SRStephen R Souza

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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