Form 483

Neuro-Fitness LLC Form 483, 2017-07-07

FDA issued a Form 483 to Neuro-Fitness LLC on 2017-07-07 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Neuro-Fitness LLC · Fall City, United States · Issued July 7, 2017

Overview

  • 6 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.

7 Jul 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Stephen R Souza

7 Jul 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Stephen R Souza

7 Jul 2017
21 CFR 820.40(a)

Not approved or obsolete document retrieval

Cited by Stephen R Souza

7 Jul 2017
21 CFR 820.40(a)

Not approved or obsolete document retrieval

Cited by Stephen R Souza

7 Jul 2017
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

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.40(a)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 6 observations

The source PDF and 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