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

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.