FDA 483 - Agiliti Health - Ellis - November 02, 2023

The FDA conducted an inspection of Raye's Inc., a medical device manufacturer in Ellis, KS, from October 30 to November 2, 2023. The inspection identified two significant observations documented on a Form FDA 483, indicating deviations from quality system requirements under the Federal Food, Drug and Cosmetic Act.

The first observation cited inadequate procedures for finished device acceptance. Specifically, an operator failed to properly execute functional testing for the Class II Platinum 6000 Assembly, omitting critical steps for the autofirm feature and dynamic response during final product verification.

Secondly, the inspection found deficiencies in procedures for ensuring that purchased products and services conform to specified requirements. An internal audit had previously noted issues with supplier controls, including a lack of necessary approval forms, certifications, and capability reviews for critical component suppliers, such as those providing compressors and plastic enclosures for the Platinum 6000 device.

These observations underscore the company's responsibility to strengthen its quality management system, particularly in areas of final product testing and supplier qualification. Raye's Inc. is required to undertake prompt and effective corrective actions to address these issues and ensure compliance with federal regulations. The firm has reportedly 'promised to correct' both observations.