FDA EIR - AgaMatrix, Inc. - November 21, 2016

An FDA inspection was conducted at AgaMatrix, Inc., a Class II medical device manufacturer in Salem, NH, on November 21, 2016. This routine, preannounced inspection, part of the FY'17 work plan under compliance program 7382.845, focused on the company's Jazz Wireless 2 System, defined as a medical device under the Federal Food, Drug, and Cosmetic Act. The inspection primarily reviewed the firm's Corrective and Preventive Actions (CAPA) and Design Controls subsystems.

During the inspection, the FDA investigator thoroughly examined various documents, including procedures and records related to complaints, CAPAs, medical device reporting (MDRs), nonconforming materials, returned materials, and design controls. The review aimed to ensure compliance with quality system regulations for medical devices.

Crucially, no objectionable conditions or violations were observed during the inspection. The CAPA and design control subsystems were found to have no issues, and all procedures were followed appropriately. As a result, no FDA Form 483 (Inspectional Observations) was issued, indicating a satisfactory inspection outcome. The company was reminded of its ongoing responsibility to monitor and enhance its quality system. This outcome suggests AgaMatrix, Inc. maintains a robust quality management system for its medical device operations.