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Form 483

Mindray DS USA, Inc. dba Mindray North America Form 483, 2016-03-31

FDA issued a Form 483 to Mindray DS USA, Inc. dba Mindray North America on 2016-03-31 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Mindray DS USA, Inc. dba Mindray North America · Mahwah, United States · Issued March 31, 2016

Overview

  • 2 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.

31 Mar 2016
21 CFR 820.198(c)

Investigation of device failures

Cited by Li Li

31 Mar 2016
21 CFR 820.198(c)

Investigation of device failures

Cited by Li Li

Inspected site

MDMindray DS USA, Inc. dba Mindray North AmericaMahwah, United States

Inspection team

LLLi Li

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(c)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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