483
MedDev Manufacturing Sdn BhdFDA 483 - MedDev Manufacturing Sdn Bhd - May 04, 2023
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
MedDev Manufacturing Sdn Bhd, a foreign medical device manufacturer in Klang, Malaysia, was inspected by the FDA. The inspection revealed two significant observations concerning inadequate record-keeping and document control procedures. Specifically, the firm failed to adequately establish device history record procedures and maintain document control procedures.
Open in Dashboard
ID · 4a1a7251-9f0c-4e87-8653-6586e558b0c6