FDA 483 - Unknown Company - March 09, 2012

An FDA inspection conducted at Hospira, Inc. in Clayton, NC, from March 8-9, 2012, identified a significant observation regarding the company's quality control processes. The inspection revealed a failure to thoroughly review unexplained discrepancies and ensure that product batches meet specifications, a key requirement under good manufacturing practices for drug products. Specifically, the observation detailed instances where Hospira failed to adequately assess the potential for smaller particles in their Hospira Propofol (NDA 77-908) product. Two Field Alert Reports, dated July 19, 2011, and February 24, 2012, documented the presence of 1,200-micron and 3,950-micron stopper particles, respectively, found in vials. While medical assessments determined these large particles were unlikely to cause patient injury due to their size, the FDA noted the firm's failure to evaluate the possibility of smaller, potentially injectable particles being present in the product. This lack of thorough investigation into product quality issues necessitates corrective actions to enhance discrepancy review procedures and ensure comprehensive risk assessment related to foreign particulates.