# FDA 483 - Jianerkang Medical Co., Ltd - November 01, 2019

Source: https://www.globalkeysolutions.net/records/483/jianerkang-medical-co-ltd/0d1c666b-814a-43b9-899d-795ae5f5d79a

> FDA 483 for Jianerkang Medical Co., Ltd on November 01, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Jianerkang Medical Co., Ltd
- Inspection Date: 2019-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jiangsu Province Jianerkang Medical Dressing Co., LTD, a finished drug product manufacturer, revealed significant deficiencies in their laboratory control system and stability program. The firm failed to establish scientifically sound test procedures for drug product assays and had inadequate in-process sampling for microbiology testing. Additionally, their stability program lacked meaningful test methods, leading to a failure to demonstrate the purity of a drug product over its expiration period.

## Related Officers

- [Launner Rulon-Torres, CSO](https://www.globalkeysolutions.net/people/launner-rulon-torres-cso/c96787dc-64ca-4feb-8806-ea05013f458b)

Company: https://www.globalkeysolutions.net/companies/jianerkang-medical-co-ltd/4cd5cca8-7e53-45e0-9fe5-42981a741cd0

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1