# FDA 483 - Lan Luo, M.D., FACC - September 16, 2025

Source: https://www.globalkeysolutions.net/records/483/lan-luo-md-facc/1d5661eb-60ac-4f9f-b6f1-89edeb3abc99

> FDA 483 for Lan Luo, M.D., FACC on September 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lan Luo, M.D., FACC
- Inspection Date: 2025-09-16
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Ocala Cardiovascular Research in Ocala, FL, revealed significant deficiencies in the conduct of investigational drug studies. The firm failed to adhere to study protocols regarding subject randomization, investigational product administration, and proper collection of safety laboratory specimens. Additionally, issues were noted with investigational product accountability, timely reporting of adverse events, and maintaining accurate and complete case histories.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/chinyere-a-asanya/5d417b03-0ebb-4903-9626-3528d9d95536)

Company: https://www.globalkeysolutions.net/companies/lan-luo-md-facc/00cc236a-5d21-42fe-83bf-32904086302b

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9