483
Biomerics Winston-SalemFDA 483 - Biomerics Winston-Salem - May 21, 2026
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
An FDA inspection of Biomerics Precision Concepts Group in Winston Salem, NC, revealed two significant observations. The firm failed to adequately document risk management processes for product realization, specifically regarding controlled storage requirements and temperature data logging. Additionally, procedures for timely complaint handling were found to be inadequately documented, with several complaint records lacking required information.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · 2edb7a5c-e04f-40d9-8853-a5bb3c6ce1c6