FDA EIR - Schering-Plough Ltd - June 20, 1997

An FDA pre-approval inspection of Schering Plough's Kenilworth, NJ facility was conducted from June 9-20, 1997, under Program 7346.832, focusing on a supplement to an existing product, Gentamicin Sulfate Soluble Powder. The inspection revealed several significant deficiencies primarily concerning quality control and validation processes. Main issues documented on an FDA-483 included: inadequate qualification of the Process Control Computer used for manufacturing, with observed temperature and RPM deviations lacking investigation; a lack of proper documentation and investigation into reported color changes observed in multiple batches during stability studies, inadequately attributed to "analyst variation"; and failure to investigate high counts of Pseudomonas cepacia found during water system validation, which exceeded established microbiological guidelines. An FDA-483, List of Inspectional Observations, was issued to management, who committed to implementing all necessary corrections and providing a written response. Due to incomplete validation at the time of inspection, a withhold recommendation was submitted, necessitating a follow-up inspection to verify the corrective actions and validation batches.