Form 483

NeuroField, Inc. Form 483, 2025-05-14

FDA issued a Form 483 to NeuroField, Inc. on 2025-05-14 with 7 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health7 observations

NeuroField, Inc. · Santa Barbara, United States · Issued May 14, 2025

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

14 May 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Kevin N Tran

14 May 2025
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Kevin N Tran

14 May 2025
21 CFR 820.30(j)

Design history file

Cited by Kevin N Tran

14 May 2025
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Kevin N Tran

14 May 2025
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Kevin N Tran

Inspected site

NINeuroField, Inc.Santa Barbara, 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 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 830.300(a)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 7 observations

The source PDF, 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