FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

WAVI CO

WAVI CO is an FDA-registered device establishment (FEI 3013757456) located in Denver, Colorado. The facility is active, registered. Its most recent FDA inspection on record (2023-03-29) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Oct 20, 2023
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
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.

Recalls (1)

Dec 8, 2023 Class II
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3013757456
Address
3957 N. Steele St., Denver, Colorado
Establishment type
Device establishment
Products / operations
Neurology, Manufacture Medical Device
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Mar 29, 2023 · Official Action Indicated (OAI)
Mar 29, 2023 · No Action Indicated (NAI)
Mar 31, 2022 · No Action Indicated (NAI)
Mar 31, 2022 · Voluntary Action Indicated (VAI)
Dec 21, 2018 · Voluntary Action Indicated (VAI)
Jan 29, 2018 · No Action Indicated (NAI)
Jan 29, 2018 · Official Action Indicated (OAI)
Form 483 observations
Mar 29, 2023, 9 observations: Lack of or inadequate process validation; Lack of or inadequate procedures; DHR - not or inadequately maintained
Mar 31, 2022, 4 observations: Lack of or inadequate procedures; Management representative; Statistical techniques - Lack of or inadequate procedures
Dec 21, 2018, 7 observations: DMR - not or inadequately maintained; Lack of procedures, or not maintained; Design validation- Lack of or inadequate procedures
Jan 29, 2018, 9 observations: Document locations, Dissemination, etc.; Lack of or inadequate procedures - Acceptance activities; Lack of or inadequate organizational structure

FDA record timeline

Recall
Class II — Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Source ›
Warning letter
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Source ›
FDA inspection
OAI classification
FDA inspection
NAI classification
Form 483
9 observations
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
4 observations
FDA inspection
VAI classification
Form 483
7 observations
FDA inspection
NAI classification
FDA inspection
OAI classification
Form 483
9 observations

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

Questions

Is WAVI CO registered with the FDA?

Yes. WAVI CO is an FDA-registered device establishment (FEI 3013757456) in Denver, Colorado. Its current registration status is Active, Registered.

Has WAVI CO received an FDA warning letter?

Yes. FDA issued a warning letter to WAVI CO; the most recent is dated Oct 20, 2023 (Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device).

What does WAVI CO do?

WAVI CO's FDA-registered operations are: Neurology, Manufacture Medical Device.

Related facilities

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

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