# FDA 483 - Haisco-USA Pharmaceuticals, Inc. - October 09, 2025

Source: https://www.globalkeysolutions.net/records/483/haisco-usa-pharmaceuticals-inc/b7045a88-7da6-43ae-bbae-ec5d8683ce56

> FDA 483 for Haisco-USA Pharmaceuticals, Inc. on October 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haisco-USA Pharmaceuticals, Inc.
- Inspection Date: 2025-10-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Haisco-USA Pharmaceuticals, Inc. in Bridgewater, NJ, revealed a significant failure in clinical study monitoring. The firm did not ensure adequate oversight by its contract research organization (CRO), leading to the enrollment of subjects who did not meet protocol-specified inclusion/exclusion criteria. This indicates a serious lapse in data verification and adherence to the investigational plan.

## Related Officers

- [Mayar M. Mussa](https://www.globalkeysolutions.net/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)

Company: https://www.globalkeysolutions.net/companies/haisco-usa-pharmaceuticals-inc/841bf104-d213-438a-8459-628b7a236b1a

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