Device establishmentActive, RegisteredFDA warning letter on file

UNITED HEALTH PRODUCTS

UNITED HEALTH PRODUCTS is an FDA-registered device establishment (FEI 3011849720) located in Mount Laurel, New Jersey. The facility is active, registered. Its most recent FDA inspection on record (2024-10-04) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 24, 2025

Bioresearch Monitoring Program/Institutional Review Board (IRB)

Find this 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

3011849720

Address

520 Fellowship Rd Ste 406-D, Mount Laurel, New Jersey

Establishment type

Device establishment

Products / operations

General Hospital, Repack or Relabel Medical Device, Develop Specifications But Do Not Manufacture At This Facility, Dental, General, Plastic Surgery

Registration status

Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file

Oct 4, 2024 · Official Action Indicated (OAI)

Form 483 observations

Oct 4, 2024, 7 observations: Other sponsor records required by FDA inadequate; Abbreviated requirements / non-significant risk study; Label does not contain required information

FDA record timeline

Mar 24, 2025

Warning letter

Bioresearch Monitoring Program/Institutional Review Board (IRB)

Oct 4, 2024

FDA inspection

OAI classification

Oct 4, 2024

Form 483

7 observations

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

Questions

Is UNITED HEALTH PRODUCTS registered with the FDA?

Yes. UNITED HEALTH PRODUCTS is an FDA-registered device establishment (FEI 3011849720) in Mount Laurel, New Jersey. Its current registration status is Active, Registered.

Has UNITED HEALTH PRODUCTS received an FDA warning letter?

Yes. FDA issued a warning letter to UNITED HEALTH PRODUCTS; the most recent is dated Mar 24, 2025 (Bioresearch Monitoring Program/Institutional Review Board (IRB)).

What does UNITED HEALTH PRODUCTS do?

UNITED HEALTH PRODUCTS's FDA-registered operations are: General Hospital, Repack or Relabel Medical Device, Develop Specifications But Do Not Manufacture At This Facility, Dental, General, Plastic Surgery.

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