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

Source: https://www.keypedia.com/records/483/thermo-fisher-biopharma-services-pte-ltd/bbcfb8dd-8893-48f3-be89-35fde20082f9

> FDA 483 for Thermo Fisher Biopharma Services PTE. LTD on May 05, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Thermo Fisher Biopharma Services PTE. LTD
- Inspection Date: 2026-05-05
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Officers

- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)
- [Ying Zhang](https://www.keypedia.com/people/ying-zhang/ac4c0170-ef07-49ec-8049-face4b5a93ee)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

Company: https://www.keypedia.com/companies/thermo-fisher-biopharma-services-pte-ltd/72530b1a-9130-4bfd-8e36-5c6aacc17485

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4