FDA 483 - Samhall AB - June 09, 2023

During an FDA inspection on June 9, 2023, medical device manufacturer Samhall AB, located in Svenstavik, Sweden, received a Form FDA 483 outlining six observations. The inspection primarily focused on compliance with electronic product radiation control and quality system regulations (21 CFR 820). Key issues included the company's failure to provide certification that its Fluoroscopy Table devices conform to applicable radiation standards, specifically lacking certification tags and proof of compliance with Diagnostic X-ray Systems requirements. The firm also lacked established quality control procedures and records for electronic product radiation safety, with no such testing conducted for Fluoroscopy Tables from 2020-2022. Under quality system regulations, Samhall AB's procedures for controlling nonconforming products were deemed inadequate, failing to properly identify and segregate affected devices. Device history records did not fully confirm manufacturing adherence to master records and regulatory requirements, lacking details like proper Trendelenburg function demonstration or comprehensive labeling information. Additionally, in-process inspections and tests lacked proper documentation, with acceptance records missing dates for critical functions and first-article inspections. Lastly, labeling for the Fluoroscopy Table device did not include a human-readable Unique Device Identification (UDI) number. Samhall AB is required to address these deficiencies with prompt corrective actions to ensure compliance with federal regulations.