FDA Sends Violation Notice to Guidant

Heart device maker Guidant Corp. said Thursday that the Food and Drug Administration found a deficiency in how the company is identifying quality problems at its St. Paul, Minn. cardiac rhythm management plant.

Guidant said that it will respond to the agency about the deficiency in early March.
The inspection was not related to another inspection back in September that resulted in a December warning letter from the FDA outlining eight deficiencies.
Guidant believes it will be ready for a follow-up inspection by mid 2006.