FDA 483 - GRAMERCY EXTREMITY ORTHOPEDICS - October 24, 2025

An FDA inspection of GRAMERCY EXTREMITY ORTHOPEDICS, a manufacturer of Class I and II medical devices, was conducted from October 22-24, 2025. The inspection identified a significant deficiency in the firm's process control procedures, specifically related to the sterilization of medical devices. Investigators observed that the company had not adequately established procedures to ensure conformance to specifications.

The main issue cited was that GRAMERCY EXTREMITY ORTHOPEDICS' sterilization procedure (P-750-002) requires dose audits for initial validation. However, titanium plate implants, particularly those from the GEO Extremity and Ankle Plating System, were not appropriately included in any product family within their standard operating procedure. Furthermore, the firm had not conducted sterilization dose audits for the metal product family since 2023, failing to adhere to the frequency specified in their own written procedures prior to the distribution of finished devices.

This observation indicates a non-compliance with the quality system requirements under the Federal Food, Drug, and Cosmetic Act for medical device manufacturing. While the FDA Form 483 itself does not mandate specific actions, GRAMERCY EXTREMITY ORTHOPEDICS is expected to implement prompt corrective and preventive actions. These actions must ensure all relevant products undergo proper sterilization validation and routine dose audits, aligning with established procedures and regulatory standards. The firm acknowledged the observation and committed to correcting the identified issues.