# FDA EIR - Francisco J. Ricart, M.D. - July 16, 2024

Source: https://www.keypedia.com/records/eir/francisco-j-ricart-md/44c6010b-690d-426e-84fe-178bcf053c47

> FDA EIR for Francisco J. Ricart, M.D. on July 16, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Francisco J. Ricart, M.D.
- Inspection Date: 2024-07-16
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An unannounced FDA inspection of Francisco J. Ricart, M.D. / CCM Clinical Research Group, located in Miami, FL, was conducted from July 2 to July 16, 2024. This "For Cause" inspection, initiated by the Center for Drug Evaluation and Research, focused on the Clinical Investigator's conduct under the Bioresearch Monitoring Clinical Investigators and Sponsor-Investigators compliance program. The inspection identified significant violations of clinical trial regulations, resulting in an FDA Form 483 with two main observations. First, Dr. Ricart failed to maintain accurate case histories, specifically citing inaccurate transcription of vital sign data from paper source documents into the electronic case report form (eCRF) for 14 out of 18 reviewed subjects. Second, the investigation was not conducted in accordance with the investigational plan, as data entry into the eCRF was not performed in "real-time" or contemporaneously as required by the protocol. Instead, paper source documents were consistently used for initial data capture and then transcribed, without these paper records being uploaded into the eCRF as stipulated. Additional issues noted during management discussions included undated/unsigned progress notes, incomplete paper rater scales, use of whiteout on a source document, and backdating of investigational product temperature logs. Dr. Ricart acknowledged the observations and committed to submitting a written response to the Agency within 15 business days. Regulatory warnings regarding potential agency actions were also provided.

## Related Documents

- [483 - 2024-07-16](https://www.keypedia.com/records/483/francisco-j-ricart-md/281d6213-9759-4a93-858d-80f82e839008)

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Company: https://www.keypedia.com/companies/francisco-j-ricart-md/6694a4f9-3b3c-4230-ad10-1010ab62ee5a

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