FDA 483 - Everest Life Sciences LLC - April 16, 2012

An FDA inspection conducted from March 28 to April 16, 2012, at Jacobus Pharmaceuticals Company, Inc., a manufacturer of active pharmaceutical ingredients and finished dosages in Plainsboro, NJ, identified significant deviations from Current Good Manufacturing Practices. The inspection documented eight key observations.

Under the Quality System, the firm failed to thoroughly investigate out-of-specification batches, such as a drug ingredient with excessive moisture, and did not assess the impact on other product lots.

Regarding Facilities and Equipment, cleaning procedures were not consistently followed or documented, with residues observed and impaired viewing windows. Manufacturing and storage facilities exhibited disrepair, including a lack of temperature mapping for cold storage, structural damage (holes, exposed walls, dust, foliage), and insufficient space. Equipment was also in disrepair, with chipped paint on milling machinery.

The Production System lacked specific manufacturing instructions and control procedures, particularly for Dapsone USP processing, including inadequate details for mixing, unclear gowning, and no glove sanitation/reuse procedures. In-process material containers were also found unlabeled.

Within the Laboratory Control System, the stability program for Dapsone tablets lacked validated, stability-indicating test methods for impurities, a repeat observation. The company also accepted component supplier test results without full in-house testing or proper evaluation of supplier reliability.

Jacobus Pharmaceuticals is required to address these observations with comprehensive corrective and preventive actions to ensure compliance with regulatory standards and safeguard product quality and safety.