# FDA 483 - Jerome Stevens Pharmaceuticals, Inc. - June 15, 2022

Source: https://www.globalkeysolutions.net/records/483/jerome-stevens-pharmaceuticals-inc/41183441-009c-4796-9784-8360913f21b6

> FDA 483 for Jerome Stevens Pharmaceuticals, Inc. on June 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jerome Stevens Pharmaceuticals, Inc.
- Inspection Date: 2022-06-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Jerome Stevens Pharmaceuticals, Inc. in Bohemia, NY, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed issues with equipment cleaning validation, analytical method verification, production and process controls, in-process material stability, drug product storage conditions, computer system data integrity, and component dispensing verification. These observations indicate a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2019-04-11](https://www.globalkeysolutions.net/records/483/jerome-stevens-pharmaceuticals-inc/028b311f-2783-4c36-8863-13423179382b)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

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