# FDA 483 - SpringWorks Therapeutics, Inc. - March 31, 2023

Source: https://www.keypedia.com/records/483/springworks-therapeutics-inc/2ad46515-ca44-4ca6-b051-dc668d7ae375

> FDA 483 for SpringWorks Therapeutics, Inc. on March 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpringWorks Therapeutics, Inc.
- Inspection Date: 2023-03-31
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of SpringWorks Therapeutics, Inc. in Durham, NC, revealed a significant issue with their clinical study conduct. The firm failed to ensure the study adhered to its protocol and investigational plan. Specifically, new tumors were incorrectly included in the calculation of target tumor sums, deviating from the Statistical Analysis Plan.

## Related Documents

- [EIR - 2023-03-31](https://www.keypedia.com/records/eir/springworks-therapeutics-inc/64d3b6cb-8f85-4ef1-b547-c99cbb573cbe)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/springworks-therapeutics-inc/45314c92-4a18-484f-b955-59d4ea2000dc

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7