Atlas

Form 483

Sharp U.K. Manufacturing (SUKM) Form 483, 2022-11-02

FDA issued a Form 483 to Sharp U.K. Manufacturing (SUKM) on 2022-11-02 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Sharp U.K. Manufacturing (SUKM) · Wrexham, United Kingdom · Issued November 2, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

2 Nov 2022
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Francis Pham

2 Nov 2022
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Francis Pham

Inspected site

SUSharp U.K. Manufacturing (SUKM)Wrexham, United Kingdom

Inspection team

GMGregory M Bessette
FPFrancis Pham

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1010.2(c)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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