# FDA 483 - Hikma Pharmaceuticals USA Inc. - September 10, 2019

Source: https://www.keypedia.com/records/483/hikma-pharmaceuticals-usa-inc/0c7b12c2-a17c-44fa-946f-a65f1960d2b1

> FDA 483 for Hikma Pharmaceuticals USA Inc. on September 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hikma Pharmaceuticals USA Inc.
- Inspection Date: 2019-09-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, a manufacturer of combination drug/device products, was cited for significant deficiencies during an FDA inspection. Observations included inadequate stability data for a drug product, failure to thoroughly investigate batch failures, and issues with maintaining device history records and establishing design review procedures for combination products. These findings indicate a lack of robust quality system controls for both drug and device aspects of their operations.

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## Related Officers

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Company: https://www.keypedia.com/companies/hikma-pharmaceuticals-usa-inc/646ab738-7dde-4473-abdb-76058836c610

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