# FDA 483 - Alvaro J. Ocampo - July 07, 2014

Source: https://www.globalkeysolutions.net/records/483/alvaro-j-ocampo/b7e731ac-996d-45c8-be1f-1bf3aab5db59

> FDA 483 for Alvaro J. Ocampo on July 07, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvaro J. Ocampo
- Inspection Date: 2014-07-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Future Care Solution, LLC, a clinical investigator in Miami, FL, revealed significant deficiencies in clinical trial conduct. The firm failed to obtain proper informed consent, report adverse effects promptly, maintain adequate case histories, and ensure accurate investigational drug accountability. These issues indicate a serious lack of adherence to regulatory requirements and good clinical practice.

## Related Officers

- [Dawn McCabe](https://www.globalkeysolutions.net/people/dawn-mccabe/48c5fe52-4cd6-4531-91c9-71dbe00b8bf2)

Company: https://www.globalkeysolutions.net/companies/alvaro-j-ocampo/ef6f2550-ac4d-4861-aa9e-788a1f95c150

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6