# FDA 483 - Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. - May 19, 2017

Source: https://www.keypedia.com/records/483/guangdong-zhanjiang-jimin-pharmaceutical-co-ltd/3d7362d5-e071-43f2-bf6b-fda5504bb5ee

> FDA 483 for Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. on May 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.
- Inspection Date: 2017-05-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. revealed significant deficiencies in the manufacturing of Piyanping 1% Hydrocortisone Lotion. Key issues included product mislabeling, with the lotion containing Dexamethasone instead of Hydrocortisone, and a lack of essential quality control testing. The firm also failed to maintain adequate facility hygiene, proper recall procedures, equipment qualification, and complete batch records.

## Related Documents

- [483 - 2017-05-19](https://www.keypedia.com/records/483/guangdong-zhanjiang-jimin-pharmaceutical-co-ltd/9e648985-d8c2-482c-b8ef-f169397b3359)
- [WARNING_LETTER - 2017-05-19](https://www.keypedia.com/records/warning_letter/guangdong-zhanjiang-jimin-pharmaceutical-co-ltd/1efb1498-fb9a-4bd7-9275-c5a70f7e0886)

## Related Officers

- [Investigator](https://www.keypedia.com/people/andrew-j-idzior/5b639c02-d062-4a5a-aa4a-8362ddfba2b6)

Company: https://www.keypedia.com/companies/guangdong-zhanjiang-jimin-pharmaceutical-co-ltd/0f0aef27-7fb5-4f54-85ff-75163c67616d

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