# FDA 483 - Daito Pharmaceutical Co., Ltd. - November 06, 2017

Source: https://www.globalkeysolutions.net/records/483/daito-pharmaceutical-co-ltd/3076416f-4c48-4816-94a9-e6132ac8bd55

> FDA 483 for Daito Pharmaceutical Co., Ltd. on November 06, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daito Pharmaceutical Co., Ltd.
- Inspection Date: 2017-11-06
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Daito Pharmaceutical Co., Ltd. in Toyama-City, Japan, a manufacturer of finished dosage drugs and APIs, was cited for significant deficiencies in laboratory controls, data integrity, record-keeping, and quality unit oversight. The inspection revealed issues including unreported trial analyses, inadequate supervisory review of electronic data, non-contemporaneous record completion, and insufficient control over GMP documents and change control procedures. These observations indicate a systemic breakdown in the firm's quality management system.

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## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/daito-pharmaceutical-co-ltd/3a27bbaf-60c1-44b3-acf3-48f8935483e8

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321