# FDA 483 - Pharbest Pharmaceuticals, Inc. - September 15, 2025

Source: https://www.keypedia.com/records/483/pharbest-pharmaceuticals-inc/57794c7f-4695-45c9-ade4-2e887bd82487

> FDA 483 for Pharbest Pharmaceuticals, Inc. on September 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharbest Pharmaceuticals, Inc.
- Inspection Date: 2025-09-15
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Pharbest Pharmaceuticals, Inc. in Farmingdale, NY, revealed significant deficiencies across quality control, data integrity, equipment qualification, and stability programs. The firm failed to establish robust analytical data review, validate computer systems, maintain adequate data backups, and conduct proper stability and annual product reviews. These issues indicate a systemic lack of written procedures, validation, and oversight in critical manufacturing and quality assurance processes.

## Related Documents

- [483 - 2022-11-10](https://www.keypedia.com/records/483/pharbest-pharmaceuticals-inc/96bc3ad9-e1df-4616-97bc-648432ec8736)

## Related Officers

- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)

Company: https://www.keypedia.com/companies/pharbest-pharmaceuticals-inc/13d87e23-46a2-4ae7-92f1-4312962b2487

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d