483
Rolenn Manufacturing IncFDA 483 - Rolenn Manufacturing Inc - December 05, 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
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.
- Person
Open in Dashboard
ID · b9ce9544-dd23-42d2-8591-28d87225ad7a