483
Rolenn Manufacturing IncFDA 483 - Rolenn Manufacturing Inc - December 05, 2024
Record Details
Rolenn Manufacturing Inc. in Riverside, CA, was inspected and received a Form 483 with four observations. The inspection revealed deficiencies in procedures for finished device acceptance, process validation, corrective and preventive actions, and employee training. These issues indicate a lack of robust quality system controls for device manufacturing and release.
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ID · b9ce9544-dd23-42d2-8591-28d87225ad7a