# FDA 483 - Weiner, Gilbert R. - November 25, 2013

Source: https://www.globalkeysolutions.net/records/483/weiner-gilbert-r/9e24920c-65c3-44b0-b674-0a3b1ab43ed6

> FDA 483 for Weiner, Gilbert R. on November 25, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Weiner, Gilbert R.
- Inspection Date: 2013-11-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspection of Gilbert R. Weiner, a clinical investigator in Aventura, FL, revealed significant deviations in the conduct of a clinical trial. Key findings included a failure to adhere to the investigational plan, inadequate maintenance of case histories, and issues with the informed consent process. These observations highlight serious deficiencies in protocol execution and documentation practices during clinical research.

## Related Documents

- [WARNING_LETTER - 2013-11-25](https://www.globalkeysolutions.net/records/warning_letter/weiner-gilbert-r/204ad51b-3054-4be8-9c18-f398e5e1389b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/craig-a-garmendia/6a17e361-7085-4d55-92b2-37fcaf2f55de)
- [Brunilda Torres](https://www.globalkeysolutions.net/people/brunilda-torres/44e5068d-d3c4-4228-9d36-24a6ec99214c)

Company: https://www.globalkeysolutions.net/companies/weiner-gilbert-r/90c5c3d4-6537-4229-b9c6-94648a204789

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