# FDA 483 - Siemens Healthcare Diagnostics, Inc. - March 02, 2018

Source: https://www.keypedia.com/records/483/siemens-healthcare-diagnostics-inc/daf6ab70-0809-43f5-9bec-a650844301e3

> FDA 483 for Siemens Healthcare Diagnostics, Inc. on March 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Siemens Healthcare Diagnostics, Inc.
- Inspection Date: 2018-03-02
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Siemens Healthcare Diagnostics, Inc. in East Walpole, MA, a medical device manufacturer, revealed multiple deficiencies in their quality system. Observations included inadequate verification of corrective and preventive actions, insufficient procedures for acceptance activities and documentation, unvalidated production software for reagent expiration dates, and undocumented equipment maintenance in controlled temperature rooms.

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- [483 - 2018-03-02](https://www.keypedia.com/records/483/siemens-healthcare-diagnostics-inc/856a76fb-a687-4760-93db-ff42f53401d4)
- [483 - 2022-03-08](https://www.keypedia.com/records/483/siemens-healthcare-diagnostics-inc/c76fd4fd-d315-4978-b99b-a283795ef61f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/siemens-healthcare-diagnostics-inc/2d2218be-bbbe-4685-81fc-9addbac958c7

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