# FDA 483 - CPE1 LLC - November 21, 2022

Source: https://www.keypedia.com/records/483/cpe1-llc/46546703-567a-4ace-b720-29103df454b1

> FDA 483 for CPE1 LLC on November 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CPE1 LLC
- Inspection Date: 2022-11-21
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of InNeuroCo, Inc. in Pembroke Pines, FL, revealed significant deficiencies in the firm's complaint handling procedures. The company failed to adequately establish and implement its complaint handling process, specifically regarding the trending of complaints by type and lot number, and maintaining complete complaint investigation records. These issues indicate a breakdown in their quality system for managing customer feedback and potential product issues.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/cpe1-llc/efb9eb62-1a70-4fde-9d3e-18601f5604b7

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6