# FDA 483 - Ashlar Medical LLC - May 09, 2019

Source: https://www.keypedia.com/records/483/ashlar-medical-llc/0077b003-7ca0-4231-b9ca-8acfbb4cd9cf

> FDA 483 for Ashlar Medical LLC on May 09, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ashlar Medical LLC
- Inspection Date: 2019-05-09
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Ashlar Medical LLC, a manufacturer of Class II medical devices in Natchitoches, LA, received seven observations during an FDA inspection. The firm was cited for significant deficiencies across its quality system, including failures in design validation, risk analysis, CAPA procedures, supplier controls, medical device reporting, complaint handling, and quality audits. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/ashlar-medical-llc/81130069-d711-4be3-9261-1064dcef0129

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea