# FDA 483 - Applied Therapeutics, Inc. - May 03, 2024

Source: https://www.keypedia.com/records/483/applied-therapeutics-inc/a737cead-7854-4045-9a2c-e0094e0b3f80

> FDA 483 for Applied Therapeutics, Inc. on May 03, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Applied Therapeutics, Inc.
- Inspection Date: 2024-05-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Applied Therapeutics, Inc. in New York, NY, revealed significant deficiencies in the conduct of a clinical study. The firm failed to adhere to its protocol and investigational plan, leading to issues such as deleted source data, numerous discrepancies in efficacy endpoint assessments, and a lack of proper documentation for data changes. These findings highlight serious concerns regarding data integrity and quality assurance in their clinical trials.

## Related Documents

- [EIR - 2024-05-03](https://www.keypedia.com/records/eir/applied-therapeutics-inc/84a00dc8-34bd-4c6c-9908-9b910a85d29c)
- [EIR - 2024-05-03](https://www.keypedia.com/records/eir/applied-therapeutics-inc/47c259e1-aeca-43ed-8549-b28b9e3d4109)
- [EIR - 2024-05-03](https://www.keypedia.com/records/eir/applied-therapeutics-inc/32257dfd-a483-479a-ac04-9c9c536cb72b)
- [483 - 2024-05-03](https://www.keypedia.com/records/483/applied-therapeutics-inc/c07c4095-34e3-4399-a0c3-bf6b1320aa32)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/applied-therapeutics-inc/fe2244da-d4e3-431c-9d1b-c193dc137bd7)

## Related Officers

- [investigator](https://www.keypedia.com/people/cheryl-a-grandinetti/db17fca7-6b39-48b9-a7f3-86817b56a9a1)
- [investigator](https://www.keypedia.com/people/benton-m-ketron/34d763d8-4374-4c8b-8dd6-dce1a83dcd01)
- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)

Company: https://www.keypedia.com/companies/applied-therapeutics-inc/c2c78220-3dc2-4cda-a16d-6e4a88d78413

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961