483
Zyno Medical LLCZyno Medical LLC – FDA 483, Feb 15, 2022
Record Details
An FDA inspection of Zyno Medical LLC in Natick, MA, a manufacturer of infusion pumps and administration sets, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for design changes, control non-conforming products, implement corrective and preventive actions, and properly handle complaints. Additionally, issues were noted in supplier evaluation and timely submission of Medical Device Reports.
View Company Profile
ID · b885e180-d85d-4d11-80d4-639c9f32adcc
Other documents for Zyno Medical LLC
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.