Atlas

Form 483

Promotus, LLC Form 483, 2017-02-27

FDA issued a Form 483 to Promotus, LLC on 2017-02-27 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Promotus, LLC · Salt Lake City, United States · Issued February 27, 2017

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.

27 Feb 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by James R Montero, Christina A Mayer

27 Feb 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by James R Montero, Christina A Mayer

Inspected site

PLPromotus, LLCSalt Lake City, United States

Inspection team

JRJames R Montero
CAChristina A Mayer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited 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