# FDA 483 - Takasago International Corporation - November 19, 2018

Source: https://www.globalkeysolutions.net/records/483/takasago-international-corporation/360748f9-806a-4b61-8682-dc0d218d5417

> FDA 483 for Takasago International Corporation on November 19, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Takasago International Corporation
- Inspection Date: 2018-11-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Takasago International Corporation in Iwata, Japan, an API intermediates manufacturer, was inspected by the FDA from November 19-22, 2018. The inspection revealed a significant deficiency in the firm's quality system, specifically regarding the lack of adequate written procedures for out-of-specification investigations. This procedural gap led to an ongoing stability failure investigation being handled informally without proper documentation or tracking.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.globalkeysolutions.net/companies/takasago-international-corporation/db988725-7258-4128-babe-c5dfd3571296

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