FDAnews Device Daily Bulletin

FDA Warning to Hospira Infusion Plant May Hint at Broader Problems

A A
An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say. The five-observation letter, dated Aug. 22, was sent to Hospira’s Lake Forest, Ill., headquarters following an April 16-19 inspection of the La Aurora de Heredia, Costa Rica, facility. The company disclosed the warning in an Aug. 23 SEC filing, which noted that the site is responsible for manufacturing most of Hospira’s infusion products.
Devices & Diagnostics Letter