483
Summit Industries Inc.Summit Industries Inc. – FDA 483, Mar 20, 2025
Record Details
An FDA inspection of Summit Industries Inc., a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow corrective and preventive action (CAPA) procedures, with numerous open CAPAs lacking timely completion of actions or root cause analyses. Additionally, production processes for devices like the Radiographic Table were not properly developed, lacking essential work instructions and quality procedures.
View Company Profile
ID · 6ba9082b-5cc3-4359-8bc0-99e74b392e5d
Other documents for Summit Industries 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.