# FDA 483 - Linxens Sweden AB - November 07, 2024

Source: https://www.globalkeysolutions.net/records/483/linxens-sweden-ab/5d9e6d1a-3b40-4b8b-aa91-c4dcf7770054

> FDA 483 for Linxens Sweden AB on November 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Linxens Sweden AB
- Inspection Date: 2024-11-07
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Linxens Sweden AB, a medical device manufacturer in Angelholm Skane, was inspected by the FDA from November 4-7, 2024. The inspection revealed two significant issues related to quality system deficiencies. Specifically, the firm lacked established procedures for design transfer and failed to adequately document process validation activities and results.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/linxens-sweden-ab/1b13d3be-7e73-446a-b435-cf569fea1e43

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8