# TAIWAN BIOTECH CO., LTD. – FDA 483, May 21, 2026

Source: https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/7347265b-beee-4302-a432-589259b4183f

> FDA 483 for TAIWAN BIOTECH CO., LTD. on May 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAIWAN BIOTECH CO., LTD.
- Inspection Date: 2026-05-21
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Taiwan Biotech Co., Ltd., a drug manufacturer in Taoyuan City, was cited for significant deficiencies in its sterile drug product manufacturing processes. Observations included failures in preventing microbial contamination, inadequate environmental monitoring, unsuitable endotoxin sample containers, and deficient laboratory controls for growth promotion tests. Additionally, employee training for visual inspections was found to be insufficient, indicating a broad range of quality system breakdowns.

## Related Documents

- [483 - 2022-09-20](https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/ab6f60ca-11ef-48f9-8682-6529304218d6) — date: September 20, 2022
- [483 - 2017-09-11](https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/3621a836-8e2f-4d1f-952a-9c4838edcb01) — date: September 11, 2017
- [WARNING_LETTER - 2017-09-11](https://www.keypedia.com/records/warning_letter/taiwan-biotech-co-ltd/22a3b66c-75de-4b25-a47f-e497676d59fc) — date: September 11, 2017

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.keypedia.com/companies/taiwan-biotech-co-ltd/90bf5095-2bd0-4ad1-973c-274a66a5201f

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3