Row1 Inc. dba Regenative Labs

Warning LetterOpen

Tyler C. Barrett President and Chief Executive Officer Row1 Inc. dba Regenative Labs 1700 W. Main Street, Suite 500 Pensacola , FL 32502 United StatesFEI 3016750083Issued Jun 21, 2023Division of Biological Products Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016750083.

Violations7

Issue DateJun 21, 2023

Product TypeBiologics

StatusOpen

Letter Details

Firm: Row1 Inc. dba Regenative Labs
Location: Tyler C. Barrett President and Chief Executive Officer Row1 Inc. dba Regenative Labs 1700 W. Main Street, Suite 500 Pensacola , FL 32502 United States
FEI Number: 3016750083
Country: United States
Issue Date: June 21, 2023
Issuing Office: Division of Biological Products Operations I
Product Type: Biologics
Status: Open

Summary

Row1 Inc. dba Regenative Labs manufactured and distributed human cellular products (ProText™, CoreText™, CryoText™ Pro, CryoText™ Plus, SecreText™, and SecreText™ Pro) derived from umbilical cord tissue that were intended for clinical use to treat various diseases through injection and other routes of administration. The company failed to comply with FDA regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) under 21 CFR Part 1271 and did not qualify for any regulatory exceptions, meaning the products were required to undergo premarket review as drugs and biological products under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The inspection conducted in March 2022 found that the company was distributing these unapproved cellular products to physicians and medical clinics throughout the United States without proper FDA authorization.

Row1 Inc. dba Regenative Labs FDA Warning Letter, June 21, 2023