FDA WARNING_LETTER - Sonesta Medical AB - June 07, 2023

The FDA issued a Warning Letter to Industrivagen 7, Solna, Sweden, following an inspection from June 5-7, 2023. The firm manufactures medical devices, specifically the Model 6210 radiographic table and Model S2 and S3 cystometric tables. These devices were found to be adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Purchasing Controls (21 CFR 820.50(a)):** Failure to establish and maintain procedures for purchased products and services to conform to requirements. The firm's Supplier Evaluation procedure lacks defined frequency, type, and extent of control over suppliers, and the contract repair/servicer and QA/RA consultant were not evaluated. The firm's responses were inadequate, as assessments are incomplete, and revised procedures were not provided. 2. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. The "Process description deviation management" procedure lacks requirements for Medical Device Reporting evaluation. Complaint records inconsistently include investigation dates/results and often omit Unique Device Identification (UDI) codes. Responses were inadequate, with incomplete reviews and unprovided revised