# FDA WARNING_LETTER - Lin, Henry, M.D. - July 01, 2009

Source: https://www.globalkeysolutions.net/records/warning_letter/lin-henry-md/89375956-876c-494a-bfb9-8d788718e840

> FDA WARNING_LETTER for Lin, Henry, M.D. on July 01, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lin, Henry, M.D.
- Inspection Date: 2009-07-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, Ref: 10-HFD-45-03-01, dated September 15, 2008, and July 1, 2009, addresses Henry Lin, M.D., regarding his conduct as sponsor-investigator and then sponsor of clinical investigation Protocol (b)(4) for investigational drug (b)(4). Inspections on September 15, 2008, and July 1, 2009, revealed non-adherence to statutory requirements and FDA regulations.

Key violations as sponsor include:
1.  **Failure to ensure proper monitoring of clinical investigations** [21 CFR 312.50 and 312.56(a)]: Dr. Lin did not monitor any aspect of the study, relying insufficiently on a Data Safety Monitoring Board (DSMB) that only monitored adverse events.
2.  **Failure to obtain a signed investigator statement (Form FDA 1572)** [21 CFR 312.53(c)(1)]: Dr. Lin allowed Dr. (b)(4) to participate as clinical investigator without obtaining a signed Form FDA 1572 from her, and the one provided was signed by Dr. Lin over two years after enrollment began.
3.  **Failure to give each participating investigator an investigator brochure** [21 CFR 312

## Related Officers

- [Leslie K. Ball](https://www.globalkeysolutions.net/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)

Company: https://www.globalkeysolutions.net/companies/lin-henry-md/342fd052-87f2-4459-8652-6ec80a985b67

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c