Form 483

LSI Solutions, Inc. Form 483, 2013-11-01

FDA issued a Form 483 to LSI Solutions, Inc. on 2013-11-01 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

LSI Solutions, Inc. · Victor, United States · Issued November 1, 2013

Overview

  • 6 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.

1 Nov 2013
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Marc S Neubauer

1 Nov 2013
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Marc S Neubauer

1 Nov 2013
21 CFR 820.90(a)

Nonconforming product control

Cited by Marc S Neubauer

1 Nov 2013
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Marc S Neubauer

1 Nov 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Marc S Neubauer

Inspected site

LSLSI Solutions, Inc.Victor, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.250(b)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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