FDA 483 - SwedencareUSA, Inc. - August 30, 2022

During an inspection of SwedenCareUSA in Rosenberg, TX, the FDA observed significant deficiencies in the firm's Foreign Supplier Verification Program (FSVP). The company failed to establish written procedures for approving foreign suppliers and conducting appropriate verification activities. Additionally, SwedenCareUSA did not adequately document verification activities or provide required FSVP records upon request.