The Food and Drug Administration, in a warning letter, told the drugmaker it could hold up approval of new products if the deficiencies are not corrected quickly.
Bristol Chief Executive Lamberto Andreotti disclosed the investigation during a conference call with analysts about Bristol's third-quarter results.
He said Bristol-Myers has told FDA what corrections it is making. He says the company must resolve the problems before FDA will approve sales of a new biologic drug to prevent rejection of transplanted organs.
