Atlas

Form 483

DSC Logistics, Inc Form 483, 2013-04-17

FDA issued a Form 483 to DSC Logistics, Inc on 2013-04-17 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

DSC Logistics, Inc · Redlands, United States · Issued April 17, 2013

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.

17 Apr 2013
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Sonya L Karsik, Marcus F Yambot

17 Apr 2013
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sonya L Karsik, Marcus F Yambot

Inspected site

DLDSC Logistics, IncRedlands, United States

Inspection team

SLSonya L Karsik
MFMarcus F Yambot

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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