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

Source: https://www.keypedia.com/records/483/swedencareusa-inc/1c02f49e-f8a0-4156-bc02-7c29aabeb94d

> FDA 483 for SwedencareUSA, Inc. on August 30, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SwedencareUSA, Inc.
- Inspection Date: 2022-08-30
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

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Company: https://www.keypedia.com/companies/swedencareusa-inc/701bc34f-0226-4dbd-bd85-1be69647be47

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab