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Form 483

Encore Medical, LP Form 483, 2021-10-28

FDA issued a Form 483 to Encore Medical, LP on 2021-10-28 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Encore Medical, LP · Austin, United States · Issued October 28, 2021

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.

28 Oct 2021
21 CFR 820.100(b)

Documentation

Cited by Daniel J Lahar

28 Oct 2021
21 CFR 820.198(c)

Investigation of device failures

Cited by Daniel J Lahar

Inspected site

EMEncore Medical, LPAustin, United States

Inspection team

DJDaniel J Lahar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)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, 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