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.
Hospira has been warned by the FDA in the past about manufacturing issues affecting its injectables business. And in 2009, the company received a warning letter for distributing infusion pumps known to have defective power cords.
The new warning “suggests Hospira’s manufacturing issues may be more systemic than investors realize,” analyst Shibani Malhotra of RBC Capital Markets wrote in a research note.
Could different answers during Hospira’s inspection interview have changed the outcome?
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