# FDA 483 - TAIWAN BIOTECH CO., LTD. - September 20, 2022

Source: https://www.keypedia.com/records/483/taiwan-biotech-co-ltd/1f9e54e0-1c99-4d74-be28-1fb24a91ed04

> FDA 483 for TAIWAN BIOTECH CO., LTD. on September 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAIWAN BIOTECH CO., LTD.
- Inspection Date: 2022-09-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of TAIWAN BIOTECH CO., LTD. in Taoyuan City, Taiwan, a sterile drug manufacturer, revealed significant deficiencies in their quality control unit and stability testing programs. Observations included unqualified vendors, non-contemporaneous record-keeping, inadequate CAPA management, and issues with incubator qualification and monitoring. Additionally, the firm failed to properly utilize stability testing results for determining appropriate storage conditions and expiration dates for their sterile drug products.

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## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1