# FDA 483 - Medicilon Preclinical Research (Shanghai) LLC - October 21, 2024

Source: https://www.globalkeysolutions.net/records/483/medicilon-preclinical-research-shanghai-llc/625b946d-cf1e-44e1-9023-3caf70427102

> FDA 483 for Medicilon Preclinical Research (Shanghai) LLC on October 21, 2024. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medicilon Preclinical Research (Shanghai) LLC
- Inspection Date: 2024-10-21
- Product Type: other
- Office Name: Center for Veterinary Medicine
- Summary: Medicilon Preclinical Research, Inc. in Shanghai, China, a nonclinical laboratory, was cited for significant deficiencies during an FDA inspection. Observations included poorly maintained animal housing and storage areas, inadequate standard operating procedures for critical lab processes, and failures in archive indexing and quality assurance documentation. These issues indicate a lack of control over facility conditions, study methods, and record-keeping, which could impact the quality and integrity of nonclinical laboratory studies.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)
- [company_representative](https://www.globalkeysolutions.net/people/ying-li/070ca96b-3060-43b3-a0d5-45c4807551e2)
- [investigator](https://www.globalkeysolutions.net/people/hugh-mcclure-iii/e7c5254e-39e9-47d4-afa0-cab9480ef6fe)

Company: https://www.globalkeysolutions.net/companies/medicilon-preclinical-research-shanghai-llc/bb21469e-53e1-4321-b8c1-cd48399f0db4

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4