# FDA 483 - Tayca Corporation - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/tayca-corporation/0e42c8a5-dac5-4a3e-ac69-f75748ddc0b7

> FDA 483 for Tayca Corporation on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tayca Corporation
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Tayca Corporation, an API manufacturer in Okayama, Japan, was inspected by the FDA, revealing a significant issue with following established procedures. The firm failed to document the extended time needed to propose corrective actions for out-of-specification results, taking 14 months to address issues from long-term stability tests. This indicates a lapse in adherence to their CAPA procedure and overall quality management system.

## Related Documents

- [483 - 2017-12-15](https://www.globalkeysolutions.net/records/483/tayca-corporation/5faaae5f-1f1b-48bc-b338-a070ad45ad48)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.globalkeysolutions.net/companies/tayca-corporation/46216ddd-c2d8-492b-bbc2-7011e93a98bf

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