# FDA 483 - Astellas Pharma Inc. - October 07, 2019

Source: https://www.keypedia.com/records/483/astellas-pharma-inc/23a6db75-8d9f-4df4-bf36-d0980ceca90d

> FDA 483 for Astellas Pharma Inc. on October 07, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Astellas Pharma Inc.
- Inspection Date: 2019-10-07
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Astellas Pharma Tech Co. Ltd. in Toyama-Shi, Japan, a drug substance intermediate manufacturer, revealed significant deficiencies in their quality control systems. Observations included a failure to follow written procedures for documenting the use of critical equipment, specifically the absence of required log books for freezers. Additionally, the firm's procedural controls for handling and documenting in-process samples were found to be inadequate, leading to unlabeled samples and process materials.

## Related Officers

- [Jacek Cieslak](https://www.keypedia.com/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [issuing_officer](https://www.keypedia.com/people/maxwell-van-tassell/dfc0fdd4-a372-41cb-8b9d-2b6a083d42e2)

Company: https://www.keypedia.com/companies/astellas-pharma-inc/9a5bc049-426d-4313-b8b8-1ce28d48fa42

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c