Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistNortec Quimica SA, a Brazilian active pharmaceutical ingredient (API) manufacturer, failed to maintain adequate controls over computerized systems used in drug manufacturing, resulting in adulterated APIs exported to the United States. FDA inspectors found over 100 deleted analytical files in spectrophotometer computers, including batch records for APIs shipped to the U.S., with no system security, individual user attribution, password protection, or data backup procedures in place. The facility's stand-alone analytical systems used common usernames without login requirements, allowing analysts unrestricted access to delete and overwrite critical manufacturing and testing data.