# FDA 483 - TAIWAN BIOTECH CO., LTD. - September 11, 2017

Source: https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/3621a836-8e2f-4d1f-952a-9c4838edcb01

> FDA 483 for TAIWAN BIOTECH CO., LTD. on September 11, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAIWAN BIOTECH CO., LTD.
- Inspection Date: 2017-09-11
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: TAIWAN BIOTECH CO., LTD. in Taoyuan City, Taiwan, was inspected regarding its sterile drug manufacturing operations. The inspection revealed significant deficiencies in environmental monitoring for aseptic processing, failures in following the stability testing program, and inadequate record-keeping for quality evaluations and deviation tracking. These issues indicate a lack of robust quality control and data integrity practices.

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## Related Officers

- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8