483
Tosoh Bioscience IncTosoh Bioscience Inc – FDA 483, Oct 16, 2018
Record Details
An FDA inspection of Tosoh Bioscience Inc. in Grove City, OH, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, control of nonconforming product, servicing activities, and process validation. These issues indicate a lack of adherence to established quality management principles.
View Company Profile
ID · d7cf3a9a-ba0e-4b96-8c6b-4d9f81fbade5
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.