# FDA 483 - Chao-Ming C. Lu, MD - August 13, 2021

Source: https://www.keypedia.com/records/483/chao-ming-c-lu-md/a1fddd8e-fb2e-4f97-9b2c-6573bafa9339

> FDA 483 for Chao-Ming C. Lu, MD on August 13, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chao-Ming C. Lu, MD
- Inspection Date: 2021-08-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Chao-Ming C. Lu, Clinical Investigator, in Hacienda Heights, CA, revealed significant deficiencies in clinical investigation practices. The inspection cited failures in maintaining adequate and accurate case histories, including informed consent documentation and numerous date discrepancies. Additionally, issues were found with investigational drug disposition records and adherence to the investigational plan, specifically regarding the timely reporting of serious adverse events.

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)
- [issuing_officer](https://www.keypedia.com/people/kaitlyn-t-dang/640abfda-d492-4136-b11d-59ed9016bd97)

Company: https://www.keypedia.com/companies/chao-ming-c-lu-md/0a28455e-e8af-4e09-9e6f-b1c26d415e07

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6