FDA completes inspection of Guidant's St. Paul facilities, notes one observation

By Lisa Kerner

Erie, Pa., Feb. 23 - Guidant Corp. said the Food and Drug Administration completed an inspection of the company's Cardiac Rhythm Management facilities in St. Paul, Minn.

The FDA provided Guidant with a Form FDA-483, noting one inspection observation.

The inspection, begun on Dec. 15 and ended on Feb. 9, was not an assessment of the adequacy of Guidant's response to its Form FDA-483 dated Sept. 1, or warning letter dated Dec. 22, according to a company news release.

Guidant said it will provide the FDA with a thorough written response to the single observation in early March. The FDA's most recent observation is similar to an observation included in its previous Form FDA-483. However, the observation references a different event pattern recently discovered by the company, the release stated.

The company believes it has completed much of the work required to address the observation on a system-wide basis. Guidant said it expects to be ready for the follow-up inspection by mid-2006.

The low frequency pattern was classified by Guidant as a pattern in November and will be referenced in the first-quarter 2006 edition of the Guidant Cardiac Rhythm Management Product Performance Report, available on the company's web site.

The events in the pattern appeared as "non-patterned" events in the fourth-quarter 2005 edition of the report.

Guidant, based in Indianapolis, develops, manufactures and markets products and services for less-invasive medical care.

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