# FDA 483 - Endologix LLC - February 20, 2020

Source: https://www.keypedia.com/records/483/endologix-llc/b2695417-9cbe-4cab-92c6-a7c1f65553da

> FDA 483 for Endologix LLC on February 20, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Endologix LLC
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Endologix Inc., a medical device manufacturer in Irvine, CA, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant issues across its quality system, including inadequate corrective and preventive actions, deficient complaint handling, failures in design verification, and insufficient control over non-conforming products and device tracking. These observations indicate a systemic breakdown in ensuring product quality and patient safety.

## Related Documents

- [483 - 2021-08-03](https://www.keypedia.com/records/483/endologix-llc/29d9a86d-c41c-4fdd-9f03-5353a2eff2ed)

## Related Officers

- [Kirtida Patel](https://www.keypedia.com/people/kirtida-patel/c62852cf-9724-4296-bc4b-de8993dcf716)
- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/endologix-llc/2e09125b-ffbc-4cc9-a37e-46b0db30d900

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