Ascom (US) Inc.May 18, 2023

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

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Record Details

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.

Company: Ascom (US) Inc.
Inspection Date: May 18, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Adaliz Santaliz-Cruz

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ID · 11e61e81-cc9a-4b06-9eb9-2ad5110d4bd7