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

Source: https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/d2ea58ea-842b-49aa-bf3d-b204fdf58e7c

> 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: International Compliance Team
- Summary: TAIWAN BIOTECH CO., LTD. in Taoyuan City, Taiwan, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in environmental monitoring for aseptic processing, failure to follow the stability testing program, and inadequate record-keeping for quality standards and deviation tracking. These issues indicate a lack of robust quality control and data integrity within the sterile drug manufacturing operations.

## Related Documents

- [483 - 2017-09-11](https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/6b0180c2-d2b9-4eda-a07d-c1dd60bf20d8)
- [483 - 2017-09-11](https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/3621a836-8e2f-4d1f-952a-9c4838edcb01)
- [WARNING_LETTER - 2017-09-11](https://www.keypedia.com/records/warning_letter/taiwan-biotech-co-ltd/22a3b66c-75de-4b25-a47f-e497676d59fc)
- [483 - 2022-09-20](https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/ea99f0a0-9703-4ed9-a693-9fb65c9327d4)
- [483 - 2022-09-20](https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/1f9e54e0-1c99-4d74-be28-1fb24a91ed04)

## 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/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321