# FDA 483 - Lianyungang Kangle Pharmaceutical Co., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/lianyungang-kangle-pharmaceutical-co-ltd/b8e35a32-1002-4ed4-9462-922c9906dd70

> FDA 483 for Lianyungang Kangle Pharmaceutical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lianyungang Kangle Pharmaceutical Co., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lianyungang Kangle Pharmaceutical Co., Ltd, an API manufacturer, was cited for significant deficiencies during an FDA inspection. Observations include inadequate Quality Assurance review of raw data and data integrity for finished product testing, a complete lack of process validation for manufacturing steps, and insufficient assessment of cleaning validities during cleaning validations. Additionally, the firm failed to qualify packaging equipment, indicating systemic issues in quality control and manufacturing processes.

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.globalkeysolutions.net/companies/lianyungang-kangle-pharmaceutical-co-ltd/40be34e0-fb10-4928-81cf-1717686c5d2e

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