# FDA 483 - Rinovum Subsidiary 2 LLC - September 15, 2023

Source: https://www.globalkeysolutions.net/records/483/rinovum-subsidiary-2-llc/912c31b7-b4c1-40f3-a839-26a47cd4d3f3

> FDA 483 for Rinovum Subsidiary 2 LLC on September 15, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rinovum Subsidiary 2 LLC
- Inspection Date: 2023-09-15
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Rinovum Subsidiary 2 LLC in Monroeville, PA, identified a significant deficiency in the firm's complaint handling system. The company failed to adequately review, evaluate, and investigate customer complaints related to potential device, labeling, and packaging failures. This issue was noted as a repeat observation from a previous inspection, highlighting a persistent non-compliance.

## Related Documents

- [483 - 2019-06-11](https://www.globalkeysolutions.net/records/483/rinovum-subsidiary-2-llc/ade5b6b9-fc06-44be-8787-5d099fe7e528)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.globalkeysolutions.net/companies/rinovum-subsidiary-2-llc/bf6fbeaa-c83b-4e13-b239-05d630112c49

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8