Atlas

Form 483

Instrumentation Lab Co Form 483, 2017-04-19

FDA issued a Form 483 to Instrumentation Lab Co on 2017-04-19 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Instrumentation Lab Co · Orangeburg, United States · Issued April 19, 2017

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.

19 Apr 2017
21 CFR 820.40(a)

Document review, approval documentation

Cited by Kwong P Lee

19 Apr 2017
21 CFR 820.70(a)

Production processes

Cited by Kwong P Lee

Inspected site

ILInstrumentation Lab CoOrangeburg, United States

Inspection team

KPKwong P Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(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