# HIKMA PHARMACEUTICALS USA INC. – FDA 483, Jul 13, 2026

Source: https://www.keypedia.com/records/483/hikma-pharmaceuticals-usa-inc/b6f4c695-e3c3-4ff0-aac3-c6dccf9c732a

> FDA 483 for HIKMA PHARMACEUTICALS USA INC. on July 13, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HIKMA PHARMACEUTICALS USA INC.
- Inspection Date: 2026-07-13
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of HIKMA PHARMACEUTICALS USA INC. in Berkeley Heights, NJ, revealed a significant deficiency in their post-marketing surveillance system. The firm lacked adequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences for combination products, specifically regarding 30-day malfunction reportability. This included a failure to document malfunction-reportability assessments for several cases involving their Fluticasone Propionate and Salmeterol Inhalation Powder product.

## Related Officers

- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/hikma-pharmaceuticals-usa-inc/5c9e9af8-ac92-437a-a08c-f2b41660f1b0

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