# FDA 483 - Atalys Asheboro LLC - July 23, 2021

Source: https://www.keypedia.com/records/483/atalys-asheboro-llc/21830015-0047-483b-99ad-d577a5bd9848

> FDA 483 for Atalys Asheboro LLC on July 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atalys Asheboro LLC
- Inspection Date: 2021-07-23
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of FPE NC LLC, a medical device manufacturer in Asheboro, NC, revealed significant deficiencies in their quality system. The firm failed to establish written procedures for Medical Device Reporting (MDR), adequately manage complaints, and properly document corrective and preventive actions. These issues indicate a lack of robust quality control processes.

## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/atalys-asheboro-llc/6daafc52-61f5-455c-ac40-af347fa8077f

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