Atlas

Form 483

Anetic Aid Ltd Form 483, 2017-12-12

FDA issued a Form 483 to Anetic Aid Ltd on 2017-12-12 with 10 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health10 observations

Anetic Aid Ltd · Shipley, United Kingdom · Issued December 12, 2017

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

12 Dec 2017
21 CFR 803.17(a)(1)

Lack of System for Event Evaluations

Cited by Samuel L Murray

12 Dec 2017
21 CFR 803.17(a)(1)

Lack of System for Event Evaluations

Cited by Samuel L Murray

12 Dec 2017
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Samuel L Murray

12 Dec 2017
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Samuel L Murray

12 Dec 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Samuel L Murray

Inspected site

AAAnetic Aid LtdShipley, United Kingdom

Inspection team

SLSamuel L Murray

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 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.200(a)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 10 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