483
OSI Batteries, LLCFDA 483 - OSI Batteries, LLC - October 28, 2024
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
OSI Batteries, LLC, a contract manufacturer of medical device battery packs in Minnetonka, MN, was cited for significant deficiencies in its quality system. The inspection revealed inadequate process control procedures for battery maintenance, production changes, and manufacturing transfers. Additionally, the firm failed to perform required internal quality audits.
- Person
Open in Dashboard
ID · b607ed6a-996a-4ea7-84dd-97d6c79775c4