# FDA 483 - Henan Lvyuan Pharmaceutical Co., Ltd. - September 26, 2025

Source: https://www.globalkeysolutions.net/records/483/henan-lvyuan-pharmaceutical-co-ltd/67b3a61c-67b2-421a-ba84-15338f02d5d9

> FDA 483 for Henan Lvyuan Pharmaceutical Co., Ltd. on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Henan Lvyuan Pharmaceutical Co., Ltd.
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Henan Lvyuan Pharmaceutical Co., Ltd. in Xinxiang County, China, an API manufacturer, received a Form FDA 483 for multiple significant quality system deficiencies. These included unvalidated analytical instruments and methods, inadequate contamination control, incomplete batch records, and a deficient quality control unit. Further observations noted poorly maintained equipment, improper equipment identification, and insufficient laboratory controls for microbiology media.

## Related Documents

- [WARNING_LETTER - 2025-09-26](https://www.globalkeysolutions.net/records/warning_letter/henan-lvyuan-pharmaceutical-co-ltd/11666e1b-1d75-469a-9896-272ddee87a1e)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.globalkeysolutions.net/companies/henan-lvyuan-pharmaceutical-co-ltd/e09c8c96-94e1-4581-b164-474be4ec6a5b

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8