# FDA 483 - Litron LLC - March 22, 2022

Source: https://www.keypedia.com/records/483/litron-llc/e528b94d-08ca-4901-b0f6-ae553e283beb

> FDA 483 for Litron LLC on March 22, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Litron LLC
- Inspection Date: 2022-03-22
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Litron LLC, a medical device contract manufacturer in Agawam, MA, was inspected by the FDA from March 9-22, 2022. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, change control, complaint handling, and employee training. These issues indicate a systemic lack of control over critical manufacturing processes and quality management.

## 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/litron-llc/488b7ece-9266-4a1d-a576-d691c75509bf

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