# FDA 483 - Zhejiang Longde Pharmaceutical Co., Ltd - April 12, 2024

Source: https://www.keypedia.com/records/483/zhejiang-longde-pharmaceutical-co-ltd/347317b7-77f6-4b4e-8b75-49864caf6672

> FDA 483 for Zhejiang Longde Pharmaceutical Co., Ltd on April 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Longde Pharmaceutical Co., Ltd
- Inspection Date: 2024-04-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Zhejiang Longde Pharmaceutical Co., Ltd, a contract manufacturer and sterilizer in Hangzhou, China, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate procedures for complaint handling, corrective and preventive actions, acceptance activities, nonconforming product control, and device history records. Additionally, the firm failed to properly identify product acceptance status and its personnel lacked familiarity with relevant USFDA regulations.

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/zhejiang-longde-pharmaceutical-co-ltd/d362fe02-8956-458d-a911-c81cb9c80077

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