# FDA 483 - Cirtec Medical - March 08, 2023

Source: https://www.globalkeysolutions.net/records/483/cirtec-medical/7936291d-e3d9-44f2-83a4-1f67e362ceae

> FDA 483 for Cirtec Medical on March 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cirtec Medical
- Inspection Date: 2023-03-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [Christopher W. Buser](https://www.globalkeysolutions.net/people/christopher-w-buser/6a11d2e7-dcfa-4542-ba81-b4c6b244ef04)

Company: https://www.globalkeysolutions.net/companies/cirtec-medical/f70ce84f-f01e-4b23-8cd5-2046b4ecb70e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b