A day after Boston Scientific won its battle to buy Guidant Corp. it received a warning from the US Food and Drug Administration related to procedures, processes and timeliness of the company's corporate quality management system, which could delay its future product approvals.

In general, the corporate warning letter notified Boston Scientific that recent inspections revealed serious regulatory problems at three facilities and advises top management that its corporate-wide corrective action plan relating to three prior warning letters issued to the company in May and August of 2005 was inadequate. The letter expresses concerns about the company's quality systems at six facilities as well as recent recalls, rather than any specific product performance issues, states the company release.

The Food and Drug Administration said that Boston Scientific had repeatedly failed to advise the government of serious safety problems with its devices, as well as quality-control issues at factories. The company's management did not properly track complaints over certain products, including its popular artery opening Taxus stent, Vaxcel catheters and needle electrodes, added the letter.

However the FDA corporate warning letter does not prevent the continued distribution of the company's products nor does it advise hospitals to discontinue using the products.