Device establishmentActive, RegisteredFDA warning letter on file

BLUE POPPY ENTERPRISES

BLUE POPPY ENTERPRISES is an FDA-registered device establishment (FEI 1000125602) located in Portland, Oregon. The facility is active, registered. Its most recent FDA inspection on record (2025-02-25) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Aug 6, 2021
New Drug/Misbranded

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
1000125602
Address
4804 SE 69TH AVE, Portland, Oregon
Establishment type
Device establishment
Products / operations
General Hospital, Develop Specifications But Do Not Manufacture At This Facility
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Feb 25, 2025 · Voluntary Action Indicated (VAI)
Jan 18, 2022 · Voluntary Action Indicated (VAI)
Jan 18, 2022 · No Action Indicated (NAI)
Feb 25, 2020 · No Action Indicated (NAI)
Feb 25, 2020 · Voluntary Action Indicated (VAI)
Feb 14, 2019 · No Action Indicated (NAI)
Mar 24, 2016 · No Action Indicated (NAI)
Jan 19, 2016 · Voluntary Action Indicated (VAI)
Dec 9, 2014 · No Action Indicated (NAI)
Aug 20, 2013 · Voluntary Action Indicated (VAI)
Dec 9, 2010 · No Action Indicated (NAI)
May 13, 2009 · Official Action Indicated (OAI)
Form 483 observations
Feb 25, 2025, 1 observation: Specifications - finished dietary supplement
Feb 25, 2020, 4 observations: Quality control operations - product complaints; investigate; Quality control returned dietary supplement; material review, disposition; Quality control - finished batch, distribution
Jan 19, 2016, 4 observations: Personnel - records - training; Returned dietary supplement - material review, disposition; Procedures - calibrating automated, mechanical equip
Aug 20, 2013, 6 observations: Physical plant - space; equipment, materials; Master manufacturing record - unique formulation; Insecticides, fungicides

FDA record timeline

FDA inspection
VAI classification
Form 483
1 observation
FDA inspection
VAI classification
FDA inspection
NAI classification
Warning letter
New Drug/Misbranded
Source ›
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
4 observations
FDA inspection
NAI classification
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
4 observations
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
6 observations
FDA inspection
NAI classification

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

Questions

Is BLUE POPPY ENTERPRISES registered with the FDA?

Yes. BLUE POPPY ENTERPRISES is an FDA-registered device establishment (FEI 1000125602) in Portland, Oregon. Its current registration status is Active, Registered.

Has BLUE POPPY ENTERPRISES received an FDA warning letter?

Yes. FDA issued a warning letter to BLUE POPPY ENTERPRISES; the most recent is dated Aug 6, 2021 (New Drug/Misbranded).

What does BLUE POPPY ENTERPRISES do?

BLUE POPPY ENTERPRISES's FDA-registered operations are: General Hospital, Develop Specifications But Do Not Manufacture At This Facility.

Related facilities

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

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