FDA WARNING_LETTER - Onkos Surgical, Inc. - April 04, 2025

**FDA Warning Letter Summary**

**Company Name:** ELEOS Limb Salvage System, Parsippany, NJ

**Inspection Dates:** February 4, 2025 - April 4, 2025

**Main Violations/Issues:** The FDA inspection identified significant violations of the Quality System Regulation (QSR) under 21 CFR Part 820, indicating that the ELEOS Limb Salvage System devices are adulterated. Key issues include the failure to establish and maintain adequate procedures to ensure that all purchased products and services meet specified quality requirements. Specifically, the company did not properly implement its "Approved Supplier List" procedure, failing to ensure compliance with ISO 13485 for Tier 1 suppliers. This includes inadequate assessment and documentation of cleaning validation processes for implant devices and instruments, and failure to address deviations and rationale in process validation reports.

**Regulatory Framework:** The violations fall under the Federal Food, Drug, and Cosmetic Act, section 501(h), 21 U.S.C. § 351(h), which mandates adherence to current good manufacturing practices.

**Required Actions:** The company must address the noted violations by ensuring compliance with QSR requirements, particularly in supplier management and process validation. This includes revising procedures to ensure all suppliers meet necessary quality standards, adequately documenting cleaning validations, and providing rationale for any deviations in process validation reports. The company is expected to submit a corrective action plan to the FDA detailing steps to rectify these issues and prevent recurrence.