Atlas

Form 483

Diazyme Laboratories Form 483, 2016-04-20

FDA issued a Form 483 to Diazyme Laboratories on 2016-04-20 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Diazyme Laboratories · Poway, United States · Issued April 20, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

20 Apr 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Sharon I Gundersen

20 Apr 2016
21 CFR 820.184

DHR content

Cited by Sharon I Gundersen

Inspected site

DLDiazyme LaboratoriesPoway, United States

Inspection team

SISharon I Gundersen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited 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