FDA 483 - Stille AB - September 28, 2023

Stille AB, a manufacturer based in Torshalla, Sweden, underwent an FDA inspection from September 25 to September 28, 2023. The inspection, conducted at their manufacturing facility, focused on the quality systems related to the production of imagiQ2 and Medstone tables. The FDA investigator identified two primary areas of concern regarding the company’s quality procedures. First, the firm"s complaint management system was found to be inadequate. The existing procedures did not clearly define how to investigate or evaluate complaints where a device failed to meet its specific technical standards. A review of several complaint records revealed that nearly 30% of the sampled cases lacked documentation of any investigation. Second, the investigator noted deficiencies in how the company handles incoming materials from suppliers. While the company’s internal procedures require documentation of arrival checks, records for critical components used in the imagiQ2 tables failed to show the results of these acceptance tests. These observations were issued under the Federal Food, Drug, and Cosmetic Act to assist the firm in reaching full compliance with quality system regulations. Stille AB is expected to respond to these findings with a plan for corrective actions and is responsible for conducting internal audits to ensure all violations are addressed. The document serves as a report of observations rather than a final agency determination of compliance.