# FDA WARNING_LETTER - Columbia University Medical Center RDRC - May 17, 2011

Source: https://www.keypedia.com/records/warning_letter/columbia-university-medical-center-rdrc/92799231-5ff8-4505-b7f4-bf4810c6ac62

> FDA WARNING_LETTER for Columbia University Medical Center RDRC on May 17, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Columbia University Medical Center RDRC
- Inspection Date: 2011-05-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Columbia University's Radioactive Drug Research Committee (RDRC) following a May 9-17, 2011 inspection, which found non-compliance with 21 CFR Part 361 governing radioactive drugs for human research. This inspection followed an April 7, 2010 clinical hold on all INDs and RDRC-approved studies using PET radioactive drugs from Kreitchman PET Center.

Key violations include:
1.  **Failure to assure drug quality (21 CFR 361.1(d)(6)):** No documentation was provided for radionuclidic standards of identity/purity or sterility/pyrogen-free preparation of parenteral radioactive drugs.
2.  **Failure to report adverse events (21 CFR 361.1(d)(8)):** Adverse events (e.g., headache, dizziness) observed in subject case report forms were not reported to the RDRC, and the RDRC lacked a mechanism for receiving such reports. The Chairman confirmed no adverse events had been reported since January 2007.
3.  **Failure to review/approve research with a quorum (21 CFR 361.1(c)(2)):** Research was approved and commenced before full RDRC board review with a quorum. Additionally, a quorum was lost during a vote due to conflicts of interest, leading to approval without

## Related Officers

- [David J. Brenner](https://www.keypedia.com/people/david-j-brenner/34dae4a4-925e-4b6d-adb5-b0f110bfdbec)
- [Leslie K. Ball](https://www.keypedia.com/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)

Company: https://www.keypedia.com/companies/columbia-university-medical-center-rdrc/4e3c8809-17ac-4064-820a-452f2bec5d4d

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