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Form 483

LTS Therapy Systems, LLC Form 483, 2014-03-25

FDA issued a Form 483 to LTS Therapy Systems, LLC on 2014-03-25 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

LTS Therapy Systems, LLC · Saint Paul, United States · Issued March 25, 2014

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.

25 Mar 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by April L Young

25 Mar 2014
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by April L Young

Inspected site

LTLTS Therapy Systems, LLCSaint Paul, United States

Inspection team

ALApril L Young

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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