Atlas

Form 483

Z Spine & Orthopaedics LLC Form 483, 2013-03-13

FDA issued a Form 483 to Z Spine & Orthopaedics LLC on 2013-03-13 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Z Spine & Orthopaedics LLC · El Paso, United States · Issued March 13, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

13 Mar 2013
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Leighton K Ngai, Roosevelt Turner

13 Mar 2013
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Leighton K Ngai, Roosevelt Turner

13 Mar 2013
21 CFR 820.198(a)

Complaints

Cited by Leighton K Ngai, Roosevelt Turner

Inspected site

ZSZ Spine & Orthopaedics LLCEl Paso, United States

Inspection team

LKLeighton K Ngai
RTRoosevelt Turner

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited 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