# FDA 483 - GURIN PRODUCTS LLC - November 08, 2019

Source: https://www.globalkeysolutions.net/records/483/gurin-products-llc/f832fdaa-b4ba-4c47-badd-2978c47cd394

> FDA 483 for GURIN PRODUCTS LLC on November 08, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GURIN PRODUCTS LLC
- Inspection Date: 2019-11-08
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of GREEN PRODUCTS LLC, an importer of Class II medical devices, revealed significant deficiencies in their quality system. The firm failed to establish and implement procedures for complaint handling, corrective and preventive actions (CAPA), and document control. Additionally, not all complaints regarding their Pulse Oximeters were properly reviewed or evaluated for necessary investigations.

## Related Officers

- [Angelica G Aziz](https://www.globalkeysolutions.net/people/angelica-g-aziz/3aea89c9-72d6-4865-984e-936dd61d2786)

Company: https://www.globalkeysolutions.net/companies/gurin-products-llc/2e16063c-70d7-491b-9aa7-0ae7fe16a761

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6