# FDA 483 - Hunan Norchem Pharmaceutical Co. Ltd. - July 28, 2017

Source: https://www.globalkeysolutions.net/records/483/hunan-norchem-pharmaceutical-co-ltd/728b361c-a1ca-4bec-9761-040f607d9899

> FDA 483 for Hunan Norchem Pharmaceutical Co. Ltd. on July 28, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hunan Norchem Pharmaceutical Co. Ltd.
- Inspection Date: 2017-07-28
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hunan Norchem Pharmaceutical Co., Ltd. in Jinshi, China, received a Form 483 with nine observations following an inspection from July 24-28, 2017. The inspection revealed significant deficiencies in the firm's quality unit, including failures in process and cleaning validation, record retention, raw material control, and quality control testing for their (b)(4) Base API. These issues indicate a systemic lack of adherence to GMP requirements, posing a risk to product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2017-07-28](https://www.globalkeysolutions.net/records/warning_letter/hunan-norchem-pharmaceutical-co-ltd/56cdd073-1f12-4bb9-872b-6be8202a4d4d)

## Related Officers

- [Principal Consultant](https://www.globalkeysolutions.net/people/zhongren-wu/416f09a6-f225-4d23-a305-34f96a5c78f0)
- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.globalkeysolutions.net/companies/hunan-norchem-pharmaceutical-co-ltd/235d19ab-9857-42d1-aa08-cf3a7af1c8fe

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd