Bernafon-MAICO Inc. 5/06/97 “Computer Validation The inspection found that the xxxx Computer System, used to add bulk quantities of solvents to the manufacturing processes (from a tank farm) for Ticlopidine and Bromocryptine Mesylate drug substances has not been validated (FDA-483 Item #16). The response to FDA-483 Item #16 is inadequate. Your firm’s commitment is to...Read More
