483
Custom RX LLCFDA 483 - Custom RX LLC - August 15, 2017
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 Custom RX, LLC in Wichita, KS, revealed significant deficiencies in aseptic processing and facility cleaning. Observations included an operator spraying gloves over open sterile drug product vials and media fills not representative of production. Additionally, the firm failed to adequately clean the ISO 5 hood after smoke studies and used commercial dish soap for sterile glassware.
Open in Dashboard
ID · b5b729a9-4f81-4c30-acfa-36cf5ce58955