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Form 483

LivaNova USA, Inc. Form 483, 2021-05-04

FDA issued a Form 483 to LivaNova USA, Inc. on 2021-05-04 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

LivaNova USA, Inc. · Houston, United States · Issued May 4, 2021

Overview

  • 1 public-safe observation is 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.

4 May 2021
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Ellen J Tave

Inspected site

LULivaNova USA, Inc.Houston, United States

Inspection team

EJEllen J Tave

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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  • 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