# FDA 483 - Weinert Fiber Optics Inc. - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/weinert-fiber-optics-inc/ca553af1-8c7d-410e-b0e4-1fc4e1a85c17

> FDA 483 for Weinert Fiber Optics Inc. on January 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Weinert Fiber Optics Inc.
- Inspection Date: 2023-01-13
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Weinert Fiber Optics Inc. in Williamsburg, VA, a manufacturer of fiber optics, was cited for significant deficiencies in its quality system. The inspection revealed inadequate establishment and implementation of corrective and preventive action (CAPA) procedures, including a lack of effectiveness checks and proper handling of open CAPAs. Additionally, the firm failed to submit a Medical Device Report (MDR) within 30 days for a serious injury involving one of its laser fibers.

## Related Officers

- [Heath A. Gerber](https://www.globalkeysolutions.net/people/heath-a-gerber/3c47dcdd-875c-4f3c-8165-839354a53d8b)
- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/weinert-fiber-optics-inc/eee3b32f-5b0e-467d-9ac9-4535f994303c

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64