# FDA 483 - Hikma Pharmaceuticals USA Inc. - November 03, 2023

Source: https://www.keypedia.com/records/483/hikma-pharmaceuticals-usa-inc/0d798230-9ea1-4d9b-8d2e-ffbff634ff89

> FDA 483 for Hikma Pharmaceuticals USA Inc. on November 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hikma Pharmaceuticals USA Inc.
- Inspection Date: 2023-11-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Hikma Pharmaceuticals USA Inc., a human sterile drug manufacturer in Cherry Hill, NJ, received an FDA Form 483 with five observations. The firm demonstrated significant deficiencies in component identity testing, failed to thoroughly investigate unexplained discrepancies related to stability and dissolution, and exhibited poor equipment cleaning and maintenance. Additionally, the company did not submit Field Alert Reports in a timely manner and lacked proper identification for laboratory samples, indicating systemic quality control and compliance issues.

## Related Documents

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## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

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