# FDA 483 - Laura A. Nussbaum, M.D. - December 06, 2024

Source: https://www.globalkeysolutions.net/records/483/laura-a-nussbaum-md/11f56ff0-b74a-4012-a553-4fda5f60a6c3

> FDA 483 for Laura A. Nussbaum, M.D. on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laura A. Nussbaum, M.D.
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: The FDA inspected Spitalul Clinic De Urgenta Pentru Copii Luis Turcanu Timisoara, Sectia Clinica, a clinical investigator site in Timisoara, Romania, from December 2-6, 2024. The inspection revealed significant failures to conduct a clinical trial in accordance with Good Clinical Practices and the investigational plan. These deficiencies included issues with subject screening, assessment administration, adverse event documentation, consent recordkeeping, and concomitant medication evaluation.

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/laura-a-nussbaum-md/f84e9435-6190-47a6-90a7-38bcfce4157a

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8