483
Junopacific Inc.Junopacific Inc. – FDA 483, Jan 24, 2025
Record Details
An FDA inspection of Junopacific Inc., a medical device manufacturer in Minneapolis, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes, including revalidation after a facility move, and did not properly control non-conforming products. These issues indicate a lack of adherence to established procedures and regulatory expectations for medical device manufacturing.
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ID · f66e3bb6-fe61-4dd0-a4b6-6cbb3fdb81c5
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