483
OSI Batteries, LLCOSI Batteries, LLC – FDA 483, Oct 28, 2024
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.
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