# FDA 483 - Meiji Seika Pharmatech Co., Ltd. - April 08, 2022

Source: https://www.globalkeysolutions.net/records/483/meiji-seika-pharmatech-co-ltd/0a564b2c-8718-495d-a6e3-b99e8aeb70ca

> FDA 483 for Meiji Seika Pharmatech Co., Ltd. on April 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meiji Seika Pharmatech Co., Ltd.
- Inspection Date: 2022-04-08
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Meiji Seika Pharma Co., Ltd. in Odawara, Japan, was inspected and cited for significant deficiencies across its laboratory and quality systems. Observations included widespread data integrity issues, failures in quality control unit procedures, and inadequate investigation of unexplained discrepancies. These issues indicate a lack of robust controls over data accuracy, quality processes, and deviation management.

## Related Documents

- [483 - 2022-04-08](https://www.globalkeysolutions.net/records/483/meiji-seika-pharmatech-co-ltd/b9040073-bdfd-4dd1-a816-ee2a3c8dcb9b)

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.globalkeysolutions.net/companies/meiji-seika-pharmatech-co-ltd/d8bf14f7-1e92-49cb-b638-7eb75bb481f3

Office: https://www.globalkeysolutions.net/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3