483
Kyphon IncFDA 483 - Kyphon Inc - August 09, 2006
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Record Details
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.
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ID · 9f38e2e3-c538-4e5b-b743-77d7aabeaae6