# FDA 483 - Jerome Stevens Pharmaceuticals, Inc. - April 11, 2019

Source: https://www.globalkeysolutions.net/records/483/jerome-stevens-pharmaceuticals-inc/028b311f-2783-4c36-8863-13423179382b

> FDA 483 for Jerome Stevens Pharmaceuticals, Inc. on April 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jerome Stevens Pharmaceuticals, Inc.
- Inspection Date: 2019-04-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Jerome Stevens Pharmaceuticals, Inc. in Bohemia, NY, revealed significant deficiencies in their postmarketing adverse drug experience reporting system. The firm lacked adequate written procedures for surveillance, evaluation, and reporting of adverse drug events, and failed to submit required periodic reports and timely 15-day alert reports. These issues indicate a systemic failure to comply with adverse drug event reporting regulations.

## Related Documents

- [483 - 2022-06-15](https://www.globalkeysolutions.net/records/483/jerome-stevens-pharmaceuticals-inc/41183441-009c-4796-9784-8360913f21b6)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/karen-l-kosar/6e58be60-f8e3-44f3-8218-8acdde249724)
- [Omadevi Somai](https://www.globalkeysolutions.net/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.globalkeysolutions.net/companies/jerome-stevens-pharmaceuticals-inc/a817cc0c-576c-4b0f-9e89-fdbf69e38686

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961