Atlas

Form 483

Advanced Medical Design Co., Ltd. Form 483, 2016-01-21

FDA issued a Form 483 to Advanced Medical Design Co., Ltd. on 2016-01-21 with 12 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health12 observations

Advanced Medical Design Co., Ltd. · New Taipei City, Taiwan · Issued January 21, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

21 Jan 2016
21 CFR 803.17(a)(1)

Lack of System for Event Evaluations

Cited by Evelyn Taha

21 Jan 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Evelyn Taha

21 Jan 2016
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Evelyn Taha

21 Jan 2016
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Evelyn Taha

21 Jan 2016
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Evelyn Taha

Inspected site

AMAdvanced Medical Design Co., Ltd.New Taipei City, Taiwan

Inspection team

ETEvelyn Taha

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x
21 CFR 820.80(e)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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