Atlas

Form 483

LTS Lohmann Therapy Systems Corp. Form 483, 2009-04-27

FDA issued a Form 483 to LTS Lohmann Therapy Systems Corp. on 2009-04-27 with 2 public-safe observations.

483· Form 483 issued2 observations

LTS Lohmann Therapy Systems Corp. · West Caldwell, United States · Issued April 27, 2009

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Apr 2009
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Gianine E Tompkins, Nicholas A Violand, Karen E Dorazio

27 Apr 2009
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Gianine E Tompkins, Nicholas A Violand, Karen E Dorazio

Inspected site

LLLTS Lohmann Therapy Systems Corp.West Caldwell, United States

Inspection team

GEGianine E Tompkins
NANicholas A Violand
KEKaren E Dorazio

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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