Form 483

Tuttnauer Usa Co. Ltd. Form 483, 2014-11-25

FDA issued a Form 483 to Tuttnauer Usa Co. Ltd. on 2014-11-25 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Tuttnauer Usa Co. Ltd. · Hauppauge, United States · Issued November 25, 2014

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.

25 Nov 2014
21 CFR 820.198(a)

Complaints

Cited by Kwong P Lee

Inspected site

TUTuttnauer Usa Co. Ltd.Hauppauge, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

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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