FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

MAGNOLIA MEDICAL TECHNOLOGIES, INC.

MAGNOLIA MEDICAL TECHNOLOGIES, INC. is an FDA-registered device establishment (FEI 3009976527) located in Seattle, Washington. The facility is active, registered. Its most recent FDA inspection on record (2025-07-10) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Sep 17, 2021
CGMP/QSR/Medical Devices/Adulterated
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number
3009976527
Address
220 W Mercer St., Seattle, Washington
Establishment type
Device establishment
Products / operations
General Hospital, Clinical Chemistry, Manufacture Medical Device
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Jul 10, 2025 · Voluntary Action Indicated (VAI)
Apr 6, 2022 · No Action Indicated (NAI)
Jul 15, 2021 · Official Action Indicated (OAI)
Jul 15, 2021 · Voluntary Action Indicated (VAI)
Feb 23, 2017 · Voluntary Action Indicated (VAI)
Feb 23, 2017 · No Action Indicated (NAI)
Jun 17, 2014 · No Action Indicated (NAI)
Form 483 observations
Jul 10, 2025, 2 observations: Conducting an Investigation; Lack of or inadequate procedures
Jul 15, 2021, 5 observations: Design changes - Lack of or Inadequate Procedures; Lack of or inadequate procedures; Investigation of device failures
Feb 23, 2017, 3 observations: Lack of or inadequate procedures; Document review, approval by designated individual; Management review - Lack of or inadequate procedures

FDA record timeline

FDA inspection
VAI classification
Form 483
2 observations
FDA inspection
NAI classification
Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
OAI classification
FDA inspection
VAI classification
Form 483
5 observations
FDA inspection
VAI classification
FDA inspection
NAI classification
Form 483
3 observations
FDA inspection
NAI classification

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is MAGNOLIA MEDICAL TECHNOLOGIES, INC. registered with the FDA?

Yes. MAGNOLIA MEDICAL TECHNOLOGIES, INC. is an FDA-registered device establishment (FEI 3009976527) in Seattle, Washington. Its current registration status is Active, Registered.

Has MAGNOLIA MEDICAL TECHNOLOGIES, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to MAGNOLIA MEDICAL TECHNOLOGIES, INC.; the most recent is dated Sep 17, 2021 (CGMP/QSR/Medical Devices/Adulterated).

What does MAGNOLIA MEDICAL TECHNOLOGIES, INC. do?

MAGNOLIA MEDICAL TECHNOLOGIES, INC.'s FDA-registered operations are: General Hospital, Clinical Chemistry, Manufacture Medical Device.

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Source: FDA public data · status as of 2026-08-22

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