Form 483

Anetic Aid Ltd. Form 483, 2017-12-14

FDA issued a Form 483 to Anetic Aid Ltd. on 2017-12-14 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

Anetic Aid Ltd. · Havant, United Kingdom · Issued December 14, 2017

Overview

  • 5 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.

14 Dec 2017
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Samuel L Murray

14 Dec 2017
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Samuel L Murray

14 Dec 2017
21 CFR 820.250(b)

Sampling plans

Cited by Samuel L Murray

14 Dec 2017
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Samuel L Murray

14 Dec 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Samuel L Murray

Inspected site

AAAnetic Aid Ltd.Havant, United Kingdom

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.250(b)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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