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483
•Cirtec Medical•March 8, 2023

FDA 483 - Cirtec Medical - March 08, 2023

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Record Details

Cirtec Medical in Los Gatos, CA, a contract manufacturer, was cited for inadequate corrective and preventive action procedures. The inspection revealed that the firm failed to open a CAPA to investigate and correct discrepancies in heat sealer calibration parameters. This lapse affected multiple lots of product manufactured prior to the correction, indicating a significant control deficiency.

Company
Cirtec Medical
Inspection Date
March 8, 2023
Product Type
Device
Office
Division of Human and Animal Food Operations - West V
Person
  • Christopher W. Buser
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ID · 7936291d-e3d9-44f2-83a4-1f67e362ceae

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