# FDA 483 - Kinkando Co., Ltd - November 09, 2018

Source: https://www.keypedia.com/records/483/kinkando-co-ltd/200742c3-916c-4de7-b8a9-5782e8515474

> FDA 483 for Kinkando Co., Ltd on November 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kinkando Co., Ltd
- Inspection Date: 2018-11-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: Kinkando Co., Ltd in Honjo, Japan, an OTC drug manufacturer, was inspected by the FDA from November 6-9, 2018. The inspection revealed significant deficiencies across laboratory, production, and quality systems, including issues with data integrity, recordkeeping, equipment identification, yield calculations, and quality control unit responsibilities. These observations indicate a lack of adherence to good manufacturing practices.

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/zhongren-wu/416f09a6-f225-4d23-a305-34f96a5c78f0)

Company: https://www.keypedia.com/companies/kinkando-co-ltd/e25bdfe4-1689-43a5-9e08-7e464d404a38

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb