483
Sofie Co.Sofie Co. – FDA 483, Sep 22, 2021
Record Details
Sofie Co., dba Sofie, a PET Drug Manufacturer in Sanford, FL, was inspected and received two observations. The inspection revealed significant and repeated issues with facility contamination control, including persistent mold and bacterial recoveries in cleanrooms, inadequate mold remediation, and inconsistent cleaning procedures. Additionally, the firm failed to follow written laboratory procedures for endotoxin testing, leading to unassessed retests and concerns about data reliability.
View Company Profile
ID · 735c79c0-5d6d-4106-ae03-4c1377701797
Other documents for Sofie Co.
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.