Atlas

Form 483

KBD Inc DBA Sperti Sunlamp Form 483, 2016-12-23

FDA issued a Form 483 to KBD Inc DBA Sperti Sunlamp on 2016-12-23 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

KBD Inc DBA Sperti Sunlamp · North Las Vegas, United States · Issued December 23, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

23 Dec 2016
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Cynthia T Cain

23 Dec 2016
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Cynthia T Cain

23 Dec 2016
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Cynthia T Cain

Inspected site

KIKBD Inc DBA Sperti SunlampNorth Las Vegas, United States

Inspection team

CTCynthia T Cain

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(i)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 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