Atlas

Form 483

NuTech Spine, Inc. Form 483, 2019-06-20

FDA issued a Form 483 to NuTech Spine, Inc. on 2019-06-20 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

NuTech Spine, Inc. · Birmingham, United States · Issued June 20, 2019

Overview

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

Inspectional observations

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

20 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Wendy R Blame

20 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Wendy R Blame

20 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Wendy R Blame

Inspected site

NSNuTech Spine, Inc.Birmingham, United States

Inspection team

WRWendy R Blame

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x

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