# FDA 483 - Biomerics IMP Mebane LLC - October 18, 2024

Source: https://www.keypedia.com/records/483/biomerics-imp-mebane-llc/cb986b51-9ab8-4288-a181-1849e1133e77

> FDA 483 for Biomerics IMP Mebane LLC on October 18, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomerics IMP Mebane LLC
- Inspection Date: 2024-10-18
- Product Type: other
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Biomerics IMP Mebane LLC, a contract manufacturer in Mebane, NC, identified significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive actions, properly establish and evaluate customer complaint procedures, and maintain adequate schedules for equipment preventive maintenance. These observations highlight a need for improved adherence to internal procedures and robust quality control.

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)
- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/biomerics-imp-mebane-llc/6421206f-28e1-41a5-bb9f-b55d5d38aa17

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7