# FDA EIR - Radiant Research - February 05, 2014

Source: https://www.keypedia.com/records/eir/radiant-research/bbd21045-eae1-496f-84f7-572f6539bc15

> FDA EIR for Radiant Research on February 05, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Radiant Research
- Inspection Date: 2014-02-05
- Product Type: drugs
- Office Name: Office of Scientific Investigations
- Summary: This FDA inspection report details an examination of Radiant Research in Pinellas Park, Florida, conducted from February 3 to February 5, 2014. The inspection was an initial assessment of the bio-clinical facility, requested by the Division of Bioequivalence and GLP Compliance, Office of Scientific Investigations. It specifically focused on Protocol #BTNF 1104, a study evaluating the safety and bioequivalence of a generic butenafine HCl cream compared to a reference listed drug and a vehicle control in treating interdigital tinea pedis. The inspection followed the regulatory framework outlined in CP 7348.001 and an assignment memo dated October 8, 2013. A thorough review of study documentation, subject records, and drug accountability procedures was performed. Notably, the inspection concluded with "no reportable observations," indicating full compliance with regulatory standards. During the close-out meeting, management confirmed no questions or concerns. As a result, no main violations or issues were identified, and no specific corrective actions were required from Radiant Research. A sample of the study drugs was collected by the investigators as part of the process.

## Related Officers

- [investigator](https://www.keypedia.com/people/linda-t-murray/2230f732-7242-45fd-98c7-eb643114c6f5)
- [investigator](https://www.keypedia.com/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)
- [company_representative](https://www.keypedia.com/people/carole-m-taylor/89fb4c65-6731-4d58-973c-423a5e129612)
- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)
- [company_representative](https://www.keypedia.com/people/anne-m-lanzen/dd5d2d5d-c912-4a14-a64d-d8c8253ee279)

Company: https://www.keypedia.com/companies/radiant-research/8089d65b-4dc9-45be-9827-6dcb16b68e76

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