Hospira Provides Manufacturing Update on Facilities in Costa Rica and IndiaBy
Hospira report in a recent filing with the US Securities and Exhange that the US Food and Drug Administration (FDA) concluded an inspection of its device manufacturing facility in La Aurora de Heredia, Costa Rica on February 25, 2015. No Form 483 observations were issued after that inspection. The inspection occurred from February 23 through February 25, 2015. As previously announced, the FDA lifted in January 2015 the import alert that had previously prohibited US importation of infusion pump devices manufactured at the company’s Costa Rica facility.
Hospira also reported that on February 25, 2015, Hospira Healthcare India Private Limited , a subsidiary of Hospira, Inc., received a Form 483 from the FDA containing 14 observations relating to an inspection of Hospira India's pharmaceutical manufacturing facility nearing commercial operation in Visakhapatnam, India. The inspection was conducted over the period from February 16 through February 25, 2015.
Hospira said it intends to respond fully and in a timely manner to the observations contained in the Form 483. The company must obtain the approval of the FDA in order to commercialize products produced at the Vizag facility.