# Tesla Biohealing, Inc. – FDA 483, Apr 16, 2026

Source: https://www.keypedia.com/records/483/tesla-biohealing-inc/ed209583-494f-42ea-b884-6137b3f538dd

> FDA 483 for Tesla Biohealing, Inc. on April 16, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tesla Biohealing, Inc.
- Inspection Date: 2026-04-16
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Tesla Biohealing, Inc. in Milford, DE, was inspected regarding its manufacturing of various Biophotonizer medical devices. The inspection revealed significant deficiencies across its quality system, including inadequate design and development validation, poor complaint handling procedures, unvalidated software, and undocumented risk management processes. Additionally, the firm failed to establish supplier evaluation criteria, properly document corrective actions, and provide correct Unique Device Identifier (UDI) information to the FDA.

## Related Documents

- [483 - 2023-03-23](https://www.keypedia.com/records/483/tesla-biohealing-inc/dc55f039-2d0d-40e5-a91b-09d924e6b537) — date: March 23, 2023
- [WARNING_LETTER - 2023-03-23](https://www.keypedia.com/records/warning_letter/tesla-biohealing-inc/538b2a15-b9cd-4acc-b86b-341a59d2a087) — date: March 23, 2023

## Related Officers

- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)
- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)
- [issuing_officer](https://www.keypedia.com/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.keypedia.com/companies/tesla-biohealing-inc/1ff5065b-3e68-4df9-a5ca-2191a8a35bf0

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8