Device establishmentActive, RegisteredFDA warning letter on file

QUICKSILVER SCIENTIFIC, INC.

QUICKSILVER SCIENTIFIC, INC. is an FDA-registered device establishment (FEI 3016181636) located in Louisville, Colorado. The facility is active, registered. Its most recent FDA inspection on record (2025-09-24) was classified NAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Oct 13, 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
3016181636
Address
1960 Cherry St., Louisville, Colorado
Establishment type
Device establishment
Products / operations
Pathology, Complaint File Establishment per 21 CFR 820.198, Manufacture Medical Device, Ear, Nose, Throat
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Sep 24, 2025 · No Action Indicated (NAI)
Sep 21, 2023 · Voluntary Action Indicated (VAI)
Form 483 observations
Sep 21, 2023, 5 observations: DMR - not or inadequately maintained; Lack of or inadequate procedures - Acceptance activities; Documented evaluation

FDA record timeline

FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
5 observations
Warning letter
New Drug/Misbranded
Source ›

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

Questions

Is QUICKSILVER SCIENTIFIC, INC. registered with the FDA?

Yes. QUICKSILVER SCIENTIFIC, INC. is an FDA-registered device establishment (FEI 3016181636) in Louisville, Colorado. Its current registration status is Active, Registered.

Has QUICKSILVER SCIENTIFIC, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to QUICKSILVER SCIENTIFIC, INC.; the most recent is dated Oct 13, 2021 (New Drug/Misbranded).

What does QUICKSILVER SCIENTIFIC, INC. do?

QUICKSILVER SCIENTIFIC, INC.'s FDA-registered operations are: Pathology, Complaint File Establishment per 21 CFR 820.198, Manufacture Medical Device, Ear, Nose, Throat.

Related facilities

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

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