# FDA 483 - Sunstar Americas, Inc. - February 10, 2023

Source: https://www.globalkeysolutions.net/records/483/sunstar-americas-inc/2dab7998-1454-49dd-9711-0886ef5adb96

> FDA 483 for Sunstar Americas, Inc. on February 10, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sunstar Americas, Inc.
- Inspection Date: 2023-02-10
- Product Type: device
- Office Name: Chicago District Office
- Summary: Sunstar Americas, Inc., a medical device manufacturer in Schaumburg, IL, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures during an FDA inspection. The firm failed to adequately document medical device recalls and did not satisfy requirements for CAPA records opened in response to a previous FDA Warning Letter, including the use of an unapproved "FDA Tracker" and numerous expired due dates. This observation is a repeat of a previous inspectional finding, indicating persistent and severe quality system issues.

## Related Documents

- [483 - 2021-02-18](https://www.globalkeysolutions.net/records/483/sunstar-americas-inc/757900ae-3b21-4da2-beea-8ccf9f0f69b1)
- [WARNING_LETTER - 2021-02-18](https://www.globalkeysolutions.net/records/warning_letter/sunstar-americas-inc/cd739b5d-3ba0-4da5-ad8a-a2010569cd40)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/sunstar-americas-inc/0ec42537-1ebf-49da-8ac8-507cd57e020a

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669