# FDA 483 - STRIVE PHARMACEUTICALS INC - June 02, 2025

Source: https://www.keypedia.com/records/483/strive-pharmaceuticals-inc/abee879c-20c2-4337-90a9-0e2262a81f98

> FDA 483 for STRIVE PHARMACEUTICALS INC on June 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: STRIVE PHARMACEUTICALS INC
- Inspection Date: 2025-06-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Strive Pharmaceuticals, Inc. in East Brunswick, NJ, received a Form 483 citing issues with equipment design and operation during drug product packaging. The inspection revealed that tablet counting and dispensing equipment was not adequately qualified, leading to underfilled units and product loss. These deficiencies resulted in customer complaints and a lack of assurance regarding accurately filled units.

## Related Officers

- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/strive-pharmaceuticals-inc/303dd80a-cd11-45d7-9993-f9a8cf2d7c75

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248