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Form 483

rms Surgical Form 483, 2022-04-01

FDA issued a Form 483 to rms Surgical on 2022-04-01 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

rms Surgical · Anoka, United States · Issued April 1, 2022

Overview

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

Inspectional observations

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

1 Apr 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jennifer S Ness, Jamie P Webb

1 Apr 2022
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Jennifer S Ness, Jamie P Webb

Inspected site

RSrms SurgicalAnoka, United States

Inspection team

JSJennifer S Ness
JPJamie P Webb

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited 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