Atlas

Form 483

Atrium Medical Corporation Form 483, 2020-02-10

FDA issued a Form 483 to Atrium Medical Corporation on 2020-02-10 with 18 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health18 observations

Atrium Medical Corporation · Merrimack, United States · Issued February 10, 2020

Overview

  • 18 public-safe observations are available for this inspection.
  • 6 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.

10 Feb 2020
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Maryam Tabatabaie

10 Feb 2020
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Maryam Tabatabaie

10 Feb 2020
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Maryam Tabatabaie

10 Feb 2020
21 CFR 820.198(c)

Investigation of device failures

Cited by Maryam Tabatabaie

10 Feb 2020
21 CFR 820.198(c)

Investigation of device failures

Cited by Maryam Tabatabaie

Inspected site

AMAtrium Medical CorporationMerrimack, United States

Inspection team

MTMaryam Tabatabaie

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.198(c)Cited across public-safe Form 483 observations3x
21 CFR 820.25(b)Cited across public-safe Form 483 observations3x
21 CFR 820.30(f)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 820.90(b)(1)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 18 observations

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