483
Thermo Fisher Biopharma Services PTE. LTDThermo Fisher Biopharma Services PTE. LTD – FDA 483, May 5, 2026
Record Details
An FDA inspection of Thermo Fisher Biopharma Services PTE. LTD (TFBS) in Singapore revealed significant deficiencies in their drug product manufacturing. The firm's visual inspection program was found inadequate, failing to properly trend or investigate critical defects and recurring container issues. Additionally, the manufacturing process was inconsistent, evidenced by numerous batch rejections and invalidated aseptic process simulations.
View Company Profile
ID · bbcfb8dd-8893-48f3-be89-35fde20082f9
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.