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

Source: https://www.globalkeysolutions.net/records/483/meiji-seika-pharmatech-co-ltd/b9040073-bdfd-4dd1-a816-ee2a3c8dcb9b

> 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 Biological Products Operations - Division I
- Summary: An FDA inspection of Meiji Seika Pharma Co., Ltd. in Odawara, Japan, revealed significant deficiencies in data integrity, quality control procedures, and discrepancy investigations. Issues included unchecked computer data accuracy, deleted audit trail sequences, uncalibrated equipment, and failures to follow quality unit responsibilities and thoroughly investigate out-of-specification results.

## Related Documents

- [483 - 2022-04-08](https://www.globalkeysolutions.net/records/483/meiji-seika-pharmatech-co-ltd/0a564b2c-8718-495d-a6e3-b99e8aeb70ca)

## 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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1