# FDA 483 - Desarrollo E Investigacion Medica Aragonesa SL - December 19, 2019

Source: https://www.globalkeysolutions.net/records/483/desarrollo-e-investigacion-medica-aragonesa-sl/b0aec3f2-23e2-49b5-bd36-bcab02eba11a

> FDA 483 for Desarrollo E Investigacion Medica Aragonesa SL on December 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Desarrollo E Investigacion Medica Aragonesa SL
- Inspection Date: 2019-12-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BIMA S.L., a medical device manufacturer in Calatayud, Spain, was cited for significant deficiencies in its quality system during an FDA inspection. Key issues include failures in complaint handling and Medical Device Reporting (MDR), inadequate validation processes, and a lack of independent review in design and quality audits. The firm also had issues with incoming product acceptance procedures, indicating broad systemic problems.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.globalkeysolutions.net/companies/desarrollo-e-investigacion-medica-aragonesa-sl/77142cea-3c9e-41ba-9e15-75fcd8231623

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