# FDA 483 - Excellus Holdings LLC - April 23, 2022

Source: https://www.keypedia.com/records/483/excellus-holdings-llc/ee4ba150-0504-45b5-b241-d3be30a950ff

> FDA 483 for Excellus Holdings LLC on April 23, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Excellus Holdings LLC
- Inspection Date: 2022-04-23
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Excellus Holdings LLC, a medical device manufacturer in San Diego, CA, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, MDR reporting, design history files, supplier management, training, and internal quality audits. These issues indicate a lack of established and followed quality management processes.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/excellus-holdings-llc/5824d422-b25b-4260-b9a6-dad76a86ad3f

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