# FDA 483 - Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc. IRB - January 23, 2026

Source: https://www.globalkeysolutions.net/records/483/hospital-espanol-auxilio-mutuo-de-puerto-rico-inc-irb/82306165-5c9e-496d-bcbd-1bef59f324f1

> FDA 483 for Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc. IRB on January 23, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc. IRB
- Inspection Date: 2026-01-23
- Product Type: other
- Office Name: San Juan District Office
- Summary: Auxilio Mutuo Hosp IRB #1 in San Juan, PR, was inspected and found to have significant deficiencies in its Institutional Review Board (IRB) operations. The inspection revealed a lack of proper documentation for meeting votes, absence of critical written procedures for reporting, and issues with IRB composition and member rosters. These findings indicate a moderate level of non-compliance with regulatory requirements for human subject protection.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.globalkeysolutions.net/companies/hospital-espanol-auxilio-mutuo-de-puerto-rico-inc-irb/03da1e53-3f4a-4a5e-bb7b-ccd5692e8997

Office: https://www.globalkeysolutions.net/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8