483
MEDICREATIONS LLCFDA 483 - MEDICREATIONS LLC - February 21, 2020
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
METACREATIONS LLC in Las Vegas, NV, was inspected by the FDA from February 13-21, 2020. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the lack of established procedures for design control and complaint handling. These issues indicate a failure to implement fundamental regulatory requirements for medical device specification developers.
Open in Dashboard
ID · 5bff821e-e197-495c-9fc3-45685a982d22