FDA hits Hospira with warning over infusion pump quality snafus

FDA officials are taking Hospira ($HSP) to task over quality problems at an infusion pump manufacturing plant in Costa Rica.

The Illinois maker of medical devices and injectable drugs disclosed in a recent regulatory filing that the FDA issued its Aug. 22 warning letter detailing the various violations. Regulators bases their assessment on an inspection of the company's plant in La Aurora de Heredia, Costa Rica from April 16 through April 19, 2012.

Many of the issues involve the company's Plum infusion pump. For example, Hospira recalled its Plum infusion pumps based on an alarm failure in February 2011, but the alarm still malfunctioned even after the company redesigned a crucial part, according to the warning letter. Subsequent parts for at least one related model caused similar issues, the FDA said. The FDA also faulted the company for setting deadlines for improving its relevant quality processes and management procedures and then for not having any proof that it completed the required actions.

A Hospira spokesperson told Reuters that the company expected to complete its switch to new alarm components for the product by 2013.

Hospira's 2012 first-quarter net income dropped a massive 73% from nearly $150 million to $40.2 million after being hit with quality issues and generic competition. But company CEO F. Michael Ball recently said that the company had been making progress on various quality improvement initiatives. Net sales for the second quarter hit just over the $1 billion mark, a nearly 3% decline over the same period in 2011.

- read the SEC filing
- here's Reuterstake

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