# FDA 483 - Cyalume Technologies, Inc. - October 19, 2022

Source: https://www.keypedia.com/records/483/cyalume-technologies-inc/ed3de364-6dba-4f3d-8e82-4b0dcd9ac1ec

> FDA 483 for Cyalume Technologies, Inc. on October 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cyalume Technologies, Inc.
- Inspection Date: 2022-10-19
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Cyalume Technologies, Inc. in W Springfield, MA, received a Form FDA 483 following an inspection related to their medical device manufacturing. The inspection revealed significant deficiencies in the firm's design control procedures, specifically concerning design changes and design output for their Single-Use Vaginal Speculum with Illumination Insert. These issues indicate a lack of proper documentation, review, and validation for critical aspects of device design and manufacturing changes.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/cyalume-technologies-inc/5756eb41-0fd3-4206-a3fa-555a1f5b9e31

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94