# FDA 483 - Ana J. Fandino - May 22, 2013

Source: https://www.keypedia.com/records/483/ana-j-fandino/49c5b140-ea8f-4005-8844-219832694963

> FDA 483 for Ana J. Fandino on May 22, 2013. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ana J. Fandino
- Inspection Date: 2013-05-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ana J. Fandino, Clinical Investigator, in Miami, FL, revealed significant deviations in the conduct of clinical investigations. The firm failed to adhere to investigational plans, exhibited poor record-keeping practices with inaccurate data entry, and maintained inadequate security for controlled investigational drugs, leading to theft. These findings indicate serious non-compliance with clinical research requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/craig-a-garmendia/6a17e361-7085-4d55-92b2-37fcaf2f55de)

Company: https://www.keypedia.com/companies/ana-j-fandino/46606029-aed2-42de-8937-49d9cf4e2cc4

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