# FDA EIR - Loreto Hierro, MD - April 16, 2021

Source: https://www.keypedia.com/records/eir/loreto-hierro-md/3cba165b-93eb-411a-bd27-4dd30a7fb4b6

> FDA EIR for Loreto Hierro, MD on April 16, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Loreto Hierro, MD
- Inspection Date: 2021-04-16
- Product Type: Drugs
- Office Name: Office of Scientific Investigations
- Summary: An FDA pre-approval data validation inspection of Clinical Investigator Dr. Loreto Hierro, based at Hospital Universitario La Paz in Madrid, Spain, was conducted from April 12 to April 16, 2021. This inspection, carried out under CPGM 7348.811, evaluated Dr. Hierro's site for compliance with federal regulations governing clinical investigations supporting New Drug Application (NDA) 214662, specifically for protocol LUM0001-304 involving LUM001 for Alagille Syndrome. The study was also regulated under EudraCT# 2013-005373-43, aligning with Spanish and EU standards.
The inspection reviewed comprehensive study documentation for three enrolled subjects, including informed consent, medical histories, laboratory results, adverse event reporting, and investigational product control. While minor protocol deviations were noted, such as out-of-window visits and some initial missing lab draws, these had been reported to the sponsor and addressed. No significant discrepancies were found between site data and sponsor data listings, including serious adverse events which were timely reported.
Crucially, no Form FDA 483, "Inspectional Observations," was issued at the conclusion of the inspection, indicating that no significant objectionable conditions were identified. Consequently, no immediate corrective or required actions were mandated as a direct result of this inspection. The investigator's findings suggested that the site maintained adequate records and conducted the study in substantial compliance with applicable regulations. The final classification of the inspection remains subject to review by central authorities.

## Related Officers

- [recipient](https://www.keypedia.com/people/loreto-hierro/20a42ec4-d498-4f01-b5ff-031ffeaf4d86)
- [investigator](https://www.keypedia.com/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)
- [other](https://www.keypedia.com/people/maria-del-carmen-diaz-fernandez/e618a9e2-56e5-4b18-bd09-05e9ae368b5b)

Company: https://www.keypedia.com/companies/loreto-hierro-md/8fe9fac4-27dd-49fb-b7ac-88c9a23f1d93

Office: https://www.keypedia.com/offices/office-of-scientific-investigations/c53ddaca-0613-4f9d-8f84-8113696f359d