# Tides Medical LLC – FDA Warning Letter, Oct 1, 2026

Source: https://www.keypedia.com/records/warning_letter/tides-medical-llc/e8e4e337-51eb-4b61-ac3b-6b8038fc30f7

> FDA WARNING_LETTER for Tides Medical LLC on October 01, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tides Medical LLC
- Inspection Date: 2026-10-01
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: On October 6, 2026, the FDA issued a warning letter to Tides Medical LLC, located in Lafayette, Louisiana, regarding its APLICOR 3D product. The agency determined that the company is distributing this product without the necessary marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. While Tides Medical claimed APLICOR 3D is a Class I liquid medication dispenser exempt from review, the FDA found its actual intended use—bioprinting personalized grafts from a patient"s own tissue to treat chronic wounds and burns—exceeds that classification. Because the company lacks an approved premarket application or investigational exemption, the device is legally considered both adulterated and misbranded. The FDA requires Tides Medical to immediately cease the unauthorized distribution of APLICOR 3D and any activities resulting in these violations. The company must submit a written response within 15 business days detailing its corrective actions and a specific timetable for preventing future issues. Failure to comply could lead to serious regulatory consequences, including product seizures, legal injunctions, or financial penalties.

## Related Officers

- [Vincent Amatrudo](https://www.keypedia.com/people/vincent-amatrudo/f8eaf620-d888-41d0-91ff-5001388a5fbe)

Company: https://www.keypedia.com/companies/tides-medical-llc/e193a6fa-c9a0-406f-87ef-1cb19d22b252

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d