The Food and Drug Administration held a meeting with Boston Scientific to talk about the repairs in the quality control problems.
A similar meeting was held in 2001 with Schering-Plough about problems with its manufacture of asthma inhalers.
But the company failed to make any amendments. This provoked the FDA to withhold approval of Clarinex, a blockbuster allergy drug.
The executives said that the meeting was very tense and Mr. Cesan was known for his autocratic style. One of the executives said that after a week there were FDA inspectors crawling in all the plants.
They found more problems and the approval of the drug Clarinex was delayed by more than a year.
The company also paid a fine of about $500 million. Mr. Cesan left the company in 2001 and has since founded an investment partnership. He is also a director of The New York Times Company.
In case of Boston Scientific if F.D.A. officials detect any defiance, the company could be in trouble.
Daniel E. Troy, a Washington lawyer who is a former F.D.A. general counsel said that in times of overall management failures the company has to show some efforts to repair the quality-control problems that were detailed in the agency's warning letter.
A lot depends upon how the company takes action and necessity changes.