483
Medicoplast International GmbHFDA 483 - Medicoplast International GmbH - April 22, 2022
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
Medicoplast International GmbH, a medical device contract sterilizer in Illingen, Germany, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in process validation, control of non-conforming product, corrective and preventive actions, and complaint handling procedures. These issues indicate a lack of robust quality system controls.
Open in Dashboard
ID · 19109be8-eeb9-4750-b277-cfb223a7c27c