Atlas

Form 483

Smith & Nephew Medical, Ltd. Form 483, 2015-07-09

FDA issued a Form 483 to Smith & Nephew Medical, Ltd. on 2015-07-09 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Smith & Nephew Medical, Ltd. · Hull, United Kingdom · Issued July 9, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

9 Jul 2015
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Lori J Silverstein

9 Jul 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Lori J Silverstein

9 Jul 2015
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Lori J Silverstein

9 Jul 2015
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Lori J Silverstein

9 Jul 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Lori J Silverstein

Inspected site

S&Smith & Nephew Medical, Ltd.Hull, United Kingdom

Inspection team

LJLori J Silverstein

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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 820.22Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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