Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany – FDA EIR, Mar 20, 2017

Halo Pharmaceutical, Inc. underwent a routine FDA Good Manufacturing Practice (GMP) surveillance inspection at its Whippany, NJ facility from March 3 to March 20, 2017. Conducted under Compliance Program 7356.002, the inspection identified six significant deficiencies, documented on a Form FDA 483. Key issues included inadequate Process Performance Qualification for a specific drug product, where out-of-specification blend uniformity results were not thoroughly investigated, indicating potential non-robust blending processes (referencing 21 CFR 211.100(a)). Another critical violation involved the failure to adequately review unexplained discrepancies and out-of-specification (OOS) results for tablet assay specifications (referencing 21 CFR 211.192). The investigation into these failures was deemed scientifically unsound, and the analytical test methods lacked sufficient instructions for sample preparation. Further deficiencies noted were substandard cleaning and maintenance of manufacturing equipment, the facility not being in a good state of repair with poor wall and ceiling surfaces, the absence of a formal rework procedure for returned products, and improper storage of raw materials and packaging components in the warehouse, leading to potential contamination. At the closeout meeting, company management, led by Vice President and Plant Manager Mr. James Cherry, committed to evaluating and implementing comprehensive corrective actions. They also pledged to submit a written response to the Agency within 15 business days. The FDA emphasized that failure to address these discrepancies could result in further regulatory actions.