Atlas

Form 483

Concert Medical, LLC Form 483, 2020-03-05

FDA issued a Form 483 to Concert Medical, LLC on 2020-03-05 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Concert Medical, LLC · Norwell, United States · Issued March 5, 2020

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

5 Mar 2020
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Maura Rooney, Preston M Lee

Inspected site

CMConcert Medical, LLCNorwell, United States

Inspection team

MRMaura Rooney
PMPreston M Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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