# FDA WARNING_LETTER - Rogerio Lobo, M.D. - June 25, 2013

Source: https://www.keypedia.com/records/warning_letter/rogerio-lobo-md/36b7676d-bcda-41c5-bec3-a1cab80d671c

> FDA WARNING_LETTER for Rogerio Lobo, M.D. on June 25, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rogerio Lobo, M.D.
- Inspection Date: 2013-06-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Rogerio A. Lobo's research office at Columbia University Medical Center (CUMC) from June 5-25, 2013, regarding his role as sponsor of clinical investigation Protocol (b)(4) of investigational drug (b)(4). The inspection, part of FDA's Bioresearch Monitoring Program, found non-adherence to statutory requirements and FDA regulations for clinical investigations and human subject protection.

Key violations include:
1.  **Failure to ensure proper monitoring and protocol adherence (21 CFR 312.50 and 312.56(a))**: Dr. Lobo failed to identify and correct a clinical investigator's failures in a timely manner.
    *   **Inadequate Informed Consent (21 CFR 321.60 and 50.20)**: Monitoring did not identify that 26 of 50 subjects lacked informed consent, and 12 subjects received investigational drug before obtaining consent.
    *   **Lapsed IRB Approval (21 CFR part 56)**: Monitoring failed to identify that IRB approval for Protocol (b)(4) lapsed from March 31 to June 3, 2011, during which 6 subjects were enrolled and treated.
    *   **Failure to Administer Correct Drug Doses**: Monitoring did not identify

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Company: https://www.keypedia.com/companies/rogerio-lobo-md/51584520-3095-4eb8-a4a8-fa995e8d42c2

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