# FDA 483 - Ascom (US) Inc. - May 18, 2023

Source: https://www.globalkeysolutions.net/records/483/ascom-us-inc/11e61e81-cc9a-4b06-9eb9-2ad5110d4bd7

> FDA 483 for Ascom (US) Inc. on May 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascom (US) Inc.
- Inspection Date: 2023-05-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ascom (US) Inc., a specification developer in Lakewood Ranch, FL, was inspected regarding its Telligence Nurse Call Systems. The inspection revealed significant deficiencies in the firm's complaint handling and investigation records. Specifically, complaint investigations lacked required details, dates, results, corrective actions, and trending analysis, indicating a failure to adequately document and evaluate product issues.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.globalkeysolutions.net/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.globalkeysolutions.net/companies/ascom-us-inc/2088b044-1ad6-4037-84e2-9dd96eeb59a2

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6