Hospira, Inc., A Pfizer Company – FDA 483, Oct 27, 2017

The FDA Form 483 details multiple observations regarding a pharmaceutical manufacturing facility.

**Key Violations and Observations:**

1. **Inadequate Discrepancy Review:** * Failure to thoroughly review "lack of effect" complaints for Bupivacaine HCl with Dextrose (Marcaine) lots 550503A, 641003A, and 641403A (approximately 50, 43, and 46 complaints respectively). No additional testing or adequate trend analysis was performed despite trend notifications. * Delayed investigation and recall for Hydromorphone HCl lot 510053, where silicone-based particulate matter was identified in 15 retain vials. Investigation took over a year to complete. * Inadequate complaint investigation for Vancomycin HCl for Injection lot 632153A, where a hair was found embedded in a stopper, without addressing potential visual inspection process inadequacies. * Failure of two endotoxin challenge samples to meet acceptance criteria (3-log reduction) during depyrogenation tunnel requalification (Validation No. 0062-00-17-0028). Adverse events reported during the period of acceptable requalification results were not evaluated.

2. **Lack of Employee Training:** * Employees performing incoming quality visual inspection