483
Dynavision Global Holdings LLCDynavision Global Holdings LLC – FDA 483, Aug 31, 2023
Record Details
Dynavision Global Holdings LLC, a medical device manufacturer in Cincinnati, OH, was inspected by the FDA, revealing significant quality system deficiencies. The firm failed to adequately establish or implement procedures for corrective and preventive actions, complaint handling, nonconforming product control, and supplier management. Additionally, design verification results for the Dynavision D2 device were not properly documented in the design history file.
View Company Profile
ID · 665330f8-9100-48fc-800f-96ba1c70804f
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.