Atlas

Form 483

Thoratec LLC Form 483, 2014-02-28

FDA issued a Form 483 to Thoratec LLC on 2014-02-28 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Thoratec LLC · Pleasanton, United States · Issued February 28, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

28 Feb 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jude C Dike, Cristina O Dar

28 Feb 2014
21 CFR 820.250(a)

Statistical techniques - Lack of or inadequate procedures

Cited by Jude C Dike, Cristina O Dar

Inspected site

TLThoratec LLCPleasanton, United States

Inspection team

JCJude C Dike
COCristina O Dar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.250(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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