483
Ascom (US) Inc.Ascom (US) Inc. – FDA 483, May 18, 2023
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.
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ID · 11e61e81-cc9a-4b06-9eb9-2ad5110d4bd7
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