FDA 483 - Linxens Sweden AB - November 07, 2024

An FDA inspection of Linxens Sweden AB, a medical device manufacturer located in Angelholm Skane, Sweden, was conducted from November 4-7, 2024. The inspection resulted in an FDA Form 483, detailing observations related to the company's quality system. Two main issues were identified. Firstly, the firm lacked established procedures for design transfer, particularly for contract-manufactured medical devices, which is critical for ensuring that product design requirements are consistently met. Secondly, the inspection revealed inadequate documentation of process validation activities and their results. Specifically, for the contract manufacturing of a Class II medical device, the Operational Qualification (OQ) for equipment did not include documented process control limits or action levels. These observations highlight areas where the company needs to enhance its compliance with quality system regulations, which are fundamental to the Federal Food, Drug, and Cosmetic Act for medical device manufacturing. Linxens Sweden AB has acknowledged these findings and committed to correcting both identified deficiencies to ensure full regulatory adherence.