483
Tolmar, Inc.Tolmar, Inc. – FDA 483, Dec 6, 2017
Record Details
TOLMAR, Inc. in Fort Collins, CO, a drug manufacturer, received a Form 483 with two observations. The inspection revealed deficiencies in computer system controls, specifically regarding unique user accounts and data integrity, as well as inadequate supplier qualification practices for raw materials. These issues indicate potential risks to product quality and data reliability.
View Company Profile
ID · 6731193a-d03f-41f2-b46a-281d9a442ceb
Other documents for Tolmar, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.