483
Pharmaron Manufacturing Services (US) LLCFDA 483 - Pharmaron Manufacturing Services (US) LLC - January 23, 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
Rhodes Technologies, an Active Pharmaceutical Ingredient manufacturer in Coventry, RI, was cited for a significant quality control issue. The firm's Quality Control Unit failed to adhere to its own written procedures for the release of bulk liquid nitrogen, a critical production material. This involved a failure to properly complete required documentation and ensure QC Director confirmation of test results before material release.
Open in Dashboard
ID · 5a3f21c6-ae2b-4f2c-b8b4-1c52615ebda9