# FDA 483 - Rolenn Manufacturing Inc - December 05, 2024

Source: https://www.globalkeysolutions.net/records/483/rolenn-manufacturing-inc/b9ce9544-dd23-42d2-8591-28d87225ad7a

> FDA 483 for Rolenn Manufacturing Inc on December 05, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rolenn Manufacturing Inc
- Inspection Date: 2024-12-05
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Rolenn Manufacturing Inc. in Riverside, CA, was inspected and received a Form 483 with four observations. The inspection revealed deficiencies in procedures for finished device acceptance, process validation, corrective and preventive actions, and employee training. These issues indicate a lack of robust quality system controls for device manufacturing and release.

## Related Officers

- [Linda Galindo](https://www.globalkeysolutions.net/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.globalkeysolutions.net/companies/rolenn-manufacturing-inc/88442bfa-c8ae-4f88-ae2d-3ea607c52e0b

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b