FDA 483 - Onkos Surgical, Inc. - April 04, 2025

The FDA conducted an inspection of Onkos Surgical, Inc., located in Parsippany, NJ, from February 4, 2025, to April 4, 2025. The inspection revealed significant compliance issues related to the company's quality control procedures for products and services received from suppliers. Key violations include inadequate procedures for supplier, purchasing, and inspection controls, as well as insufficient validation processes for cleaning implant products.

Specifically, the firm's standard operating procedures (SOPs) failed to ensure consistent control and quality over received products and services. The "Design Controls" and "Protocol Data Report" SOPs were found lacking in establishing mechanisms for final cleaning validations. These procedures did not adequately evaluate implant product cleaning families, leading to discrepancies in product design and geometrical configurations without proper justification.

Additionally, the review of final cleaning validations associated with device history records (DHRs) revealed that Onkos Surgical approved validations despite vendors failing to test critical parameters, such as maximum device quantities per cleaning run. This oversight resulted in infection-related complaints, including instances of patient revision surgeries and amputations.

The FDA's observations require Onkos Surgical to conduct internal audits to identify and rectify these violations. The company must establish robust procedures to ensure compliance with quality system requirements, focusing on supplier management and validation processes to prevent future compliance issues.