483
SRI Healthcare LLCFDA 483 - SRI Healthcare LLC - July 10, 2025
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 SRI Healthcare LLC, a repacker in Mebane, NC, revealed significant deficiencies in their quality system oversight. The firm failed to conduct required management review meetings and did not perform scheduled quality audits. These issues indicate a breakdown in maintaining the suitability and effectiveness of their quality system, potentially impacting the quality of sterilized kits distributed to medical facilities.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · 3e18e692-378d-4a37-999c-79e1db9e5654