483
Viant Medical CompanyFDA 483 - Viant Medical Company - August 22, 2018
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 MedPlast Medical, Inc. in Grand Rapids, MI, a contract manufacturer and sterilizer, revealed two significant observations. The firm failed to establish adequate procedures for controlling environmental conditions in its clean room and for implementing a robust corrective and preventive action (CAPA) system, including statistical analysis of quality data. These issues indicate deficiencies in the firm's quality system.
Open in Dashboard
ID · ef8f22b5-ee7a-4340-8ab6-afdd8987a19d