# FDA 483 - Les Encres LLC - April 01, 2025

Source: https://www.keypedia.com/records/483/les-encres-llc/fe1b3233-50f1-47e0-8b03-93946f18cdc5

> FDA 483 for Les Encres LLC on April 01, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Les Encres LLC
- Inspection Date: 2025-04-01
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Les Encres LLC, a private labeler in Lenoir City, TN, received a Form 483 with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including inadequate procedures for complaint handling, medical device reporting, corrective and preventive actions, supplier control, training, and document control. Many of these issues were repeat observations from a previous inspection, indicating a systemic lack of compliance.

## Related Officers

- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.keypedia.com/companies/les-encres-llc/50cf5804-4e8a-4532-9b9e-3d936d9b7fc9

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