FDA EIR - Hospira, Inc., A Pfizer Company - August 16, 2026

An FDA inspection was conducted at Hospira, Inc. in McPherson, KS, from July 29 to August 16, 2013. This directed inspection focused on Drug Quality Reporting System (DQRS) and NDA-Field Alert Reports, initiated due to several priority DQRS reports received by the FDA. The primary violation identified was Hospira's failure to file seven NDA-Field Alerts for complaints involving confirmed glass particulate contamination in sterile lyophilized products between December 2012 and July 2013. This issue was highlighted as a recurring observation, having been verbally noted in the three preceding inspections regarding the requirement to file NDA-Field Alerts within three days, as stipulated by 21 CFR 314.81(b)(1)(ii). Management was engaged in discussions about this non-compliance and the implications for distributed products, though they expressed confidence in their products despite the identified reporting lapses. Additionally, the inspection reviewed numerous "Lack of Efficacy" complaints for products like Marcaine HCl w/ Dextrose and Bupivacaine Spinal Injection. While retention samples for one lot of Bupivacaine were found within specifications, the persistent high volume of these complaints was noted, prompting the firm to refer to an internal position paper on the issue. The inspection underscores the necessity for timely and accurate reporting of adverse product events to ensure patient safety and regulatory compliance.