FDA 483 - Zebra Technologies International LLC - July 23, 2025

An FDA inspection conducted from July 21-23, 2025, at Zebra Technologies International LLC, a medical device manufacturer in Morris Plains, NJ, identified significant deficiencies in the firm's complaint handling procedures. The inspection revealed that the company's established procedures for receiving, reviewing, and evaluating complaints were inadequate, impacting its quality system.Specifically, 11 out of 11 reviewed complaints lacked evaluation of critical manufacturing documentation such as Packing Lists, Certificates of Analysis, or Job Jackets, as mandated by the company's internal procedures. Furthermore, a substantial number of complaints were missing essential information including product part numbers, Unique Device Identifiers (UDIs), "Complaint Type," and complainant contact details without adequate justification. The FDA noted a lack of objective evidence that the firm made a good faith effort to obtain this crucial information, compromising the thoroughness and conclusions of investigations. The company has received 19 complaints since 2022 related to its Safe-T-Vue devices.These observations indicate non-compliance with the quality system requirements outlined in the Federal Food, Drug, and Cosmetic Act, which governs medical device manufacturing. While the FDA 483 is an observation document, it signals that Zebra Technologies International LLC must implement comprehensive corrective actions to revise and properly execute its complaint handling processes to ensure compliance and improve product safety and quality. The firm acknowledged the observation and "promised to correct."