# FDA 483 - Biomerics Alajuela - May 05, 2023

Source: https://www.globalkeysolutions.net/records/483/biomerics-alajuela/791e4ee7-f240-4764-a9c4-0ef55dbdcd68

> FDA 483 for Biomerics Alajuela on May 05, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biomerics Alajuela
- Inspection Date: 2023-05-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Precision Concepts Costa Rica S.A., a medical device contract manufacturer, revealed one observation concerning inadequate procedures for finished device acceptance. This indicates a deficiency in the firm's quality system regarding product release controls.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/biomerics-alajuela/5c442aa7-a8af-4897-a99a-f77e1e3d7a78

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