483
Westmed, Inc.FDA 483 - Westmed, Inc. - December 11, 2019
Discuss this record with AI
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.
Record Details
An FDA inspection of Westmed, Inc. in Tucson, AZ, a medical device manufacturer, revealed two significant observations. The firm failed to document corrective and preventive action (CAPA) activities following a product recall, and records of complaint investigations were incomplete. These issues are considered serious as they relate to quality system requirements and product safety.
Open in Dashboard
ID · 50370a12-7104-412b-909f-6af974b3bf0b