# FDA 483 - Draeger Medical Systems, Inc. - April 12, 2013

Source: https://www.keypedia.com/records/483/draeger-medical-systems-inc/ceb5824a-3711-4535-866f-23af8976ea9d

> FDA 483 for Draeger Medical Systems, Inc. on April 12, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Draeger Medical Systems, Inc.
- Inspection Date: 2013-04-12
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Draegar Medical Systems, Inc. in Andover, MA, a medical device manufacturer, received a Form FDA-483 with four observations during an inspection. The observations highlight deficiencies in documenting corrective and preventive actions, inadequate document control for Design History Files, and insufficient design verification for product specifications. Additionally, the firm's quality audit procedures were found to be inadequately established regarding reaudits.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maura-rooney/b9731b44-8033-4add-9863-545851b86bf7)

Company: https://www.keypedia.com/companies/draeger-medical-systems-inc/361285bb-e4c9-4778-bd58-59caf9885b61

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