Skye Biologics Holdings LLC

Warning LetterOpen

Christopher M.B. Sharp Chief Executive Officer Skye Biologics Holdings LLC 2255 Campus Dr El Segundo , CA 90245-0001 United StatesFEI 3005340932Issued Dec 16, 2024Center for Biologics Evaluation and Research (CBER)

View Letter

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 3005340932.

Violations11

Issue DateDec 16, 2024

Product TypeBiologics

StatusOpen

Letter Details

Firm: Skye Biologics Holdings LLC
Location: Christopher M.B. Sharp Chief Executive Officer Skye Biologics Holdings LLC 2255 Campus Dr El Segundo , CA 90245-0001 United States
FEI Number: 3005340932
Country: United States
Issue Date: December 16, 2024
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

Skye Biologics Holdings LLC manufactured unapproved placental connective tissue matrix allograft products (BioECM™) derived from umbilical cord that violated the Federal Food, Drug, and Cosmetic Act by operating as unlicensed biological products without required drug approval. The company's manufacturing operations deviated from current good manufacturing practice (CGMP) requirements under 21 CFR parts 210 and 211, rendering the products adulterated. The FDA inspection conducted in late 2022 identified significant violations of manufacturing standards, methods, facilities, and controls that made the introduction or delivery of these products into interstate commerce prohibited.

Skye Biologics Holdings LLC FDA Warning Letter, December 16, 2024