# FDA 483 - Kyphon Inc - August 09, 2006

Source: https://www.globalkeysolutions.net/records/483/kyphon-inc/9f38e2e3-c538-4e5b-b743-77d7aabeaae6

> FDA 483 for Kyphon Inc on August 09, 2006. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyphon Inc
- Inspection Date: 2006-08-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: During an inspection, Kyphon Inc, a medical device manufacturer in Sunnyvale, CA, was cited for significant quality system deficiencies. Observations included a failure to implement process control procedures, inadequate documentation of corrective and preventive actions, and a lack of verification for the effectiveness of implemented CAPAs.

## Related Officers

- [Christine M. Parmentier](https://www.globalkeysolutions.net/people/christine-m-parmentier/80fd27af-861d-48c5-9a39-a3569b704cd0)

Company: https://www.globalkeysolutions.net/companies/kyphon-inc/adc3c8d9-6aba-4c38-b75a-5ab4e8dcac94

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