MAST Biosurgery USA, Inc.

Warning LetterOpen

Mr. Lukas Bluecher Chief Executive Officer MAST Biosurgery USA, Inc. 11 Hughes Irvine , CA 92618 United States lbluecher@mastbio.comFEI 3004661493Issued Dec 17, 2025Center for Devices and Radiological Health

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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 3004661493.

Violations4

Issue DateDec 17, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: MAST Biosurgery USA, Inc.
Location: Mr. Lukas Bluecher Chief Executive Officer MAST Biosurgery USA, Inc. 11 Hughes Irvine , CA 92618 United States lbluecher@mastbio.com
FEI Number: 3004661493
Country: United States
Issue Date: December 17, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

MAST Biosurgery USA, Inc. was found to manufacture surgical polymeric mesh devices (SurgiWrap FROST) in violation of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820, rendering the products adulterated. During an FDA inspection in August 2025, investigators identified a critical failure to establish adequate procedures preventing product contamination, including a specific gap where the firm did not perform required LAL endotoxin testing on SurgiWrap devices despite pre-market commitments to the FDA in November 2020 to conduct such testing. The firm's September 2025 response to FDA 483 observations was deemed insufficient to address the noted quality system violations.

MAST Biosurgery USA, Inc. FDA Warning Letter, December 17, 2025