"We are better than we were, but we have to get better," says Baxter CEO Robert Parkinson, reflecting to analysts last week on the company's receipt of an FDA warning letter. Baxter is currently evaluating the letter, which concerns two manufacturing plants in Puerto Rico.
Analyst Rick Wise of Leerink Swann speculates the warning "looks and feels worse than it probably is," according to Reuters. "History makes us see this letter as a new blow," likely because of the Colleague infusion pump calamity.
The FDA last April ordered Baxter to recall and destroy the 200,000 pumps. A July "reminder" from the agency nudged the company to complete the action by providing a refund or replacement to customers as well as a guide to help them select an alternative.
The current warning concerns the anesthetic agent Suprane in addition to amino acid and critical care products. According to Parkinson, violations relate to how the company conducts quality-related investigations and reports them to the FDA.