CAPAs and quality data cited for Guidant.

During an Aug. 22-Sept. 1, 2005, inspection of the Guidant Corp, Minneapolis, MN, FDA concluded that the firm's St. Paul location was not in conformance with the current GMP requirements of the QS regulation.

Violations noted in the Dec. 22, 2005, warning letter for Guidant, which manufactures implantable cardiovascular defibrillators and pacemakers, included failure to adequately ensure process results, failure to establish and maintain procedures for CAPA when process deviations occurred, and failure to analyze quality data.

Specifically, failure data from unnamed equipment was not routinely collected and analyzed.

Furthermore, the firm failed to document activities in the DHR and failed to maintain the DHR.

For example, several DHRs documented neither the completion of acceptance inspection activities, the type of inspection, nor the results of the acceptance inspection.

Guidant could not be reached for comment by deadline. Doc. 13691W