# FDA 483 - Biokit, S.A. - July 11, 2022

Source: https://www.globalkeysolutions.net/records/483/biokit-sa/90eed3c7-47ad-41e8-9ea4-58ef736e6599

> FDA 483 for Biokit, S.A. on July 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biokit, S.A.
- Inspection Date: 2022-07-11
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Biokit S.A. in L'lissa D'Amunt (Barcelona), Spain, revealed significant quality system deficiencies. Observations included inadequate design verification failing to confirm design output meets input, a lack of established procedures to control non-conforming products, and the use of obsolete documents in active processes. These issues indicate a need for improved quality management practices at the device manufacturing facility.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/biokit-sa/8c5b6598-58ab-4a7e-956e-2c56482b9d6b

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321