Atlas

Form 483

Rogers Foam Corporation Form 483, 2026-02-25

FDA issued a Form 483 to Rogers Foam Corporation on 2026-02-25 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Rogers Foam Corporation · Mount Sterling, United States · Issued February 25, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

25 Feb 2026
ISO 13485:2016 Clause 7.5.6

Procedures for validation of processes lack required elements

Cited by Shannon A Gregory

25 Feb 2026
ISO 13485:2016 Clause 7.5.6

Process for production and service provision not validated

Cited by Shannon A Gregory

25 Feb 2026
ISO 13485:2016 Clause 7.5.6

Procedures for validation of processes lack required elements

Cited by Shannon A Gregory

25 Feb 2026
ISO 13485:2016 Clause 7.5.6

Process for production and service provision not validated

Cited by Shannon A Gregory

Inspected site

RFRogers Foam CorporationMount Sterling, United States

Inspection team

SAShannon A Gregory

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 4 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