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

An FDA preapproval inspection was conducted at Schering Plough in Kenilworth, NJ, from June 9-20, 1997, under Program 7346.832. The inspection covered a supplement for product application changes. Several significant issues were identified across manufacturing and quality control, resulting in an FDA-483 List of Inspectional Observations being issued to company management.

Key violations included the inadequate qualification of a Process Control Computer used for temperature and RPM control during manufacturing. Observed temperature deviations from setpoints lacked documented explanations or investigations. Additionally, the firm failed to adequately document and investigate reported color changes in drug substance stability studies, attributing them to "analyst variation" without formal degradation assessment. A critical deficiency was the absence of investigations into elevated counts of Pseudomonas cepacia and other high microbial counts from carbon bed samples, which exceeded established water system validation guidelines.

Schering Plough's Senior Director Worldwide Research, Quality Assurance, committed to addressing all observations and providing a written response. Consequently, a withhold recommendation was submitted, and a follow-up inspection is necessary to verify implemented corrective actions and validation batches.