FDA 483 - Hospira, Inc., A Pfizer Company - January 04, 2012

This FDA Form 483, issued to Hospira Inc., a drug manufacturer located at 1776 Centennial Dr, McPherson, KS, details observations from an inspection conducted between November 28, 2011, and January 4, 2012.

**Observation 1:** The firm lacks written procedures for production and process controls to ensure drug product identity, strength, quality, and purity. Specifically, the EYo vision light inspection for products like Marcaine HCl, Demerol HCl Inj, Morphine Sulfate Inj, Heparin Lock Flush Solution USP, Humalog 100, Fabrazyme, and Vancomycin HCl has not been validated regarding personnel qualification, inspection speeds, and technique using seeded lyophilized vials. Observations included no inversion of vials/ampuls/cartridges for particulate inspection, and training plans for vision inspection employees do not include seeded qualification panels. Employees inspecting lyophilized product verbally stated they do not inspect the top of the lyophilized cake, and semi-automated systems are not set up for this.

**Observation 2:** Procedures to prevent microbiological contamination of sterile drug products are not established and written. The design of personnel entryways, traffic flow, and gowning practices promote microbial contamination. Aseptic filling room personnel are allowed to frequent common public areas (offices, restrooms, cafeteria) without changing out of dedicated plant scrubs and shoes, which are then worn back into aseptic fill rooms. Locker rooms are