Atlas

Form 483

Linemaster Switch Corporation Form 483, 2012-01-12

FDA issued a Form 483 to Linemaster Switch Corporation on 2012-01-12 with 5 public-safe observations.

483· Form 483 issued5 observations

Linemaster Switch Corporation · Woodstock, United States · Issued January 12, 2012

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

12 Jan 2012
21 CFR 820.30(g)

Design validation - documentation

Cited by Jeffrey J Thibodeau

12 Jan 2012
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Jeffrey J Thibodeau

12 Jan 2012
21 CFR 820.40(a)

Not approved or obsolete document retrieval

Cited by Jeffrey J Thibodeau

12 Jan 2012
21 CFR 820.50(a)(1)

Documented evaluation

Cited by Jeffrey J Thibodeau

12 Jan 2012
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Jeffrey J Thibodeau

Inspected site

LSLinemaster Switch CorporationWoodstock, United States

Inspection team

JJJeffrey J Thibodeau

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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