# FDA 483 - AQUISEL S.L.U. - May 15, 2019

Source: https://www.globalkeysolutions.net/records/483/aquisel-slu/620e1f35-c4de-44ae-af9a-44e7e82f9392

> FDA 483 for AQUISEL S.L.U. on May 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AQUISEL S.L.U.
- Inspection Date: 2019-05-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: AQUI-SEL, S.L.U. in Abrera, Barcelona, Spain, a manufacturer of Class 2 medical devices, was inspected by the FDA from May 13-15, 2019. The inspection revealed deficiencies in the firm's quality system, specifically regarding the lack of established statistical techniques for sampling plans and the use of unapproved documents. These observations indicate a need for improved quality control and document management practices.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/aquisel-slu/ec24ebab-35c9-4aff-87da-d24b55eda4e7

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd