# FDA 483 - Linemaster Switch Corporation - February 15, 2023

Source: https://www.keypedia.com/records/483/linemaster-switch-corporation/f1617dab-fbd8-4ef1-8fb6-ffff15650c28

> FDA 483 for Linemaster Switch Corporation on February 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Linemaster Switch Corporation
- Inspection Date: 2023-02-15
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Linemaster Switch Corporation in Woodstock, CT, a medical device manufacturer, was issued a Form FDA 483 following an inspection from February 7-15, 2023. The inspection revealed significant deficiencies in equipment validation, documentation of rework and reevaluation activities, and incomplete device history records. These observations indicate a lack of adequate quality system controls over critical manufacturing processes.

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Company: https://www.keypedia.com/companies/linemaster-switch-corporation/651f7d58-aaf7-4ee7-a5d5-320a27d1c4d7

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