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Form 483

Angiodynamics, Inc. Form 483, 2011-01-13

FDA issued a Form 483 to Angiodynamics, Inc. on 2011-01-13 with 4 public-safe observations.

483· Form 483 issued4 observations

Angiodynamics, Inc. · Queensbury, United States · Issued January 13, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

13 Jan 2011
21 CFR 803.17(a)(1)

Lack of System for Event Evaluations

Cited by Catherine M Beer

13 Jan 2011
21 CFR 806.10(a)(1)

Report of risk to health

Cited by Catherine M Beer

13 Jan 2011
21 CFR 820.30(c)

Design input - documentation

Cited by Catherine M Beer

13 Jan 2011
21 CFR 820.198(b)

Review and evaluation for investigation

Cited by Catherine M Beer

Inspected site

AIAngiodynamics, Inc.Queensbury, United States

Inspection team

CMCatherine M Beer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.198(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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