Atlas

Form 483

SYNAPTIC MEDICAL CORPORATION Form 483, 2026-03-31

FDA issued a Form 483 to SYNAPTIC MEDICAL CORPORATION on 2026-03-31 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

SYNAPTIC MEDICAL CORPORATION · Carlsbad, United States · Issued March 31, 2026

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.

31 Mar 2026
21 CFR 812.40

Sponsors' general responsibilities

Cited by Samson O Oluseye, Jose A Leyva

Inspected site

SMSYNAPTIC MEDICAL CORPORATIONCarlsbad, United States

Inspection team

SOSamson O Oluseye
JAJose A Leyva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.40Cited 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