483
Harmac Medical Products, Inc.FDA 483 - Harmac Medical Products, Inc. - February 11, 2022
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 Harmac Medical Products, Inc. in Buffalo, NY, a medical device contract manufacturer, identified two significant observations. The firm was cited for inadequate procedures regarding the verification and validation of corrective and preventive actions. Additionally, software used in production for dimensional analysis of components was found to be unvalidated for its intended use.
Open in Dashboard
ID · 557e2b54-654a-449b-95e8-31f8f1af312e