Thermo Fisher Biopharma Services PTE. LTDMay 5, 2026

FDA 483 - Thermo Fisher Biopharma Services PTE. LTD - May 05, 2026

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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.

Company: Thermo Fisher Biopharma Services PTE. LTD
Inspection Date: May 5, 2026
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Operations
People: Madushini N. Dharmasena
Ying Zhang
Yiwei Li

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ID · bbcfb8dd-8893-48f3-be89-35fde20082f9