Jon D. Tryggestad
Chief Executive Officer and Co-Owner
Stratus Biosystems, LLC dba CellGenuity Regenerative Science
913 S Main St Ste 215
Grapevine , TX 76051-7575
United StatesFEI 3014171113Issued Jun 5, 2023Division of Biological Products Operations II
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 3014171113.
Jon D. Tryggestad
Chief Executive Officer and Co-Owner
Stratus Biosystems, LLC dba CellGenuity Regenerative Science
913 S Main St Ste 215
Grapevine , TX 76051-7575
United States
FEI Number
3014171113
Country
United States
Issue Date
June 05, 2023
Issuing Office
Division of Biological Products Operations II
Product Type
Biologics
Status
Open
Summary
Stratus Biosystems, LLC (operating as CellGenuity Regenerative Science) manufactured and distributed allogeneic cell and tissue products derived from umbilical cord, amniotic membrane, and amniotic fluid intended for injection to treat various diseases, which qualified as biological products and human cells, tissues, or cellular and tissue-based products (HCT/Ps) subject to FDA regulation under 21 CFR Part 1271. The company failed to comply with HCT/P regulatory requirements, specifically not meeting the criteria outlined in 21 CFR 1271.10(a), which governs eligibility and manufacturing standards for these products. The violations were identified during an FDA inspection conducted between October 26 and November 10, 2021, at the company's Grapevine, Texas facility.
Stratus Biosystems, LLC dba CellGenuity Regenerative Science FDA Warning Letter, June 5, 2023
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