# FDA 483 - Toyobo Co. Ltd. - February 25, 2021

Source: https://www.keypedia.com/records/483/toyobo-co-ltd/5ddad59f-670f-4370-ad82-1388ad774e79

> FDA 483 for Toyobo Co. Ltd. on February 25, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Toyobo Co. Ltd.
- Inspection Date: 2021-02-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Toyobo Co. Ltd. in Otsu, Shiga, Japan, a sterile drug manufacturer, was cited for significant deficiencies across its quality system. Observations included failures in discrepancy review, environmental monitoring, aseptic practices, laboratory record completeness, and quality unit oversight, indicating a systemic lack of adherence to GMP principles and data integrity. The firm's practices showed issues with data integrity, personnel training, and validation of critical systems.

## Related Documents

- [483 - 2018-01-23](https://www.keypedia.com/records/483/toyobo-co-ltd/bbac9cc0-5862-453e-a530-4705a8f4df44)
- [483 - 2018-01-15](https://www.keypedia.com/records/483/toyobo-co-ltd/6a5fa569-95eb-48c0-a9b9-070ef96fa235)
- [483 - 2019-07-30](https://www.keypedia.com/records/483/toyobo-co-ltd/fbacef8e-d077-4541-b097-cc06e346bad0)
- [483 - 2021-02-25](https://www.keypedia.com/records/483/toyobo-co-ltd/fb9405d5-4ccd-4337-bb13-84c354abefbc)
- [WARNING_LETTER - 2021-02-25](https://www.keypedia.com/records/warning_letter/toyobo-co-ltd/93bb6541-a2a7-490b-addf-4c3c51348f17)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/toyobo-co-ltd/f6d8fe5d-b154-45db-bff8-bd0be01d2fa9

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