# FDA 483 - Myriad Fiber Imaging Technologies, Inc. - July 31, 2025

Source: https://www.keypedia.com/records/483/myriad-fiber-imaging-technologies-inc/17445b35-57de-4635-bd78-b551c1370849

> FDA 483 for Myriad Fiber Imaging Technologies, Inc. on July 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Myriad Fiber Imaging Technologies, Inc.
- Inspection Date: 2025-07-31
- Product Type: device
- Office Name: New England District Office
- Summary: Myriad Fiber Imaging Technologies, Inc. in Dudley, MA, was inspected and received a Form 483 with two observations. The inspection revealed issues with production process controls, specifically a failure to follow established procedures for environmental conditions during device assembly. Additionally, the firm lacked established preventative maintenance schedules for critical production equipment.

## Related Documents

- [483 - 2022-07-29](https://www.keypedia.com/records/483/myriad-fiber-imaging-technologies-inc/968cd893-ae43-41c9-8f2d-780e448eb83f)

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/myriad-fiber-imaging-technologies-inc/b39f964e-fbb0-4094-84d0-f7c56b168eb1

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144