# FDA 483 - Leslie H. Lundahl, PhD - December 15, 2023

Source: https://www.keypedia.com/records/483/leslie-h-lundahl-phd/45c17b7b-d1d4-4cf6-afa1-7e89f5530567

> FDA 483 for Leslie H. Lundahl, PhD on December 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Leslie H. Lundahl, PhD
- Inspection Date: 2023-12-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Leslie H. Lundahl, PhD, a sponsor-investigator in Detroit, MI, was cited for significant non-compliance regarding an Investigational New Drug (IND). The firm failed to submit annual reports for an IND since 2018, resulting in its termination, while continuing to enroll and dose subjects. Additionally, protocol amendments for the study were not submitted when changes went into effect.

## Related Officers

- [investigator](https://www.keypedia.com/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)

Company: https://www.keypedia.com/companies/leslie-h-lundahl-phd/85ba439d-2c7f-4c92-b265-b2581499bd3f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0