Atlas

Form 483

TELEMED Form 483, 2026-02-12

FDA issued a Form 483 to TELEMED on 2026-02-12 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

TELEMED · Vilnius, Lithuania · Issued February 12, 2026

Overview

  • 1 public-safe observation is 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.

12 Feb 2026
ISO 13485:2016 Clause 8.5.2

Corrective action procedures not documented

Cited by Benjamin E Bowen

Inspected site

TTELEMEDVilnius, Lithuania

Inspection team

BEBenjamin E Bowen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 8.5.2Cited 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