Device establishmentActive, RegisteredFDA warning letter on file

TESLA BIOHEALING, INC.

TESLA BIOHEALING, INC. is an FDA-registered device establishment (FEI 3023229437) located in Milford, Delaware. The facility is active, registered. Its most recent FDA inspection on record (2023-03-23) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Aug 10, 2023

Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

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

3023229437

Address

111 Mccoy St, Milford, Delaware

Establishment type

Device establishment

Products / operations

Physical Medicine, Manufacture Medical Device, Ear, Nose, Throat, Remanufacture Medical Device, Manufacture Medical Device for Another Party (Contract Manufacturer), Obstetrics/Gynecology, 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

Mar 23, 2023 · Official Action Indicated (OAI)

Form 483 observations

Mar 23, 2023, 4 observations: Equipment suitability & capability; Lack of or inadequate organizational structure; Design validation - user needs and intended uses

FDA record timeline

Aug 10, 2023

Warning letter

Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

Source ›

Mar 23, 2023

FDA inspection

OAI classification

Mar 23, 2023

Form 483

4 observations

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

Questions

Is TESLA BIOHEALING, INC. registered with the FDA?

Yes. TESLA BIOHEALING, INC. is an FDA-registered device establishment (FEI 3023229437) in Milford, Delaware. Its current registration status is Active, Registered.

Has TESLA BIOHEALING, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to TESLA BIOHEALING, INC.; the most recent is dated Aug 10, 2023 (Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)).

What does TESLA BIOHEALING, INC. do?

TESLA BIOHEALING, INC.'s FDA-registered operations are: Physical Medicine, Manufacture Medical Device, Ear, Nose, Throat, Remanufacture Medical Device, Manufacture Medical Device for Another Party (Contract Manufacturer), Obstetrics/Gynecology, General Hospital, Develop Specifications But Do Not Manufacture At This Facility.

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