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Form 483

Qiagen Sciences LLC Form 483, 2021-07-16

FDA issued a Form 483 to Qiagen Sciences LLC on 2021-07-16 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Qiagen Sciences LLC · Germantown, United States · Issued July 16, 2021

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.

16 Jul 2021
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jude C Dike

16 Jul 2021
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jude C Dike

Inspected site

QSQiagen Sciences LLCGermantown, United States

Inspection team

JCJude C Dike

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)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, 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