Form 483

Durasafe Inc Form 483, 2009-11-24

FDA issued a Form 483 to Durasafe Inc on 2009-11-24 with 2 public-safe observations.

483· Form 483 issued2 observations

Durasafe Inc · City Of Industry, United States · Issued November 24, 2009

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.

24 Nov 2009
21 CFR 820.160(b)

Distribution records

Cited by Aliza Chalapong Asawes, Linda H Sirisuk

24 Nov 2009
21 CFR 820.198(a)

General

Cited by Aliza Chalapong Asawes, Linda H Sirisuk

Inspected site

DIDurasafe IncCity Of Industry, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.160(b)Cited 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