Edwards, Hospira Warn Investors of Receipt of FDA Warning Letters

| 30 May 2013 | By Alexander Gaffney, RAC •

Two major life sciences companies, Hospira and Edwards Lifesciences, have separately warned their respective investors about their receipt of Warning Letters from the US Food and Drug Administration (FDA) this week regarding alleged quality failures at their facilities.

Edwards Lifesciences

For medical device manufacturer Edwards, the FDA Warning Letter follows a February 2013 inspection of the company's manufacturing facility in Draper, Utah. The facility reportedly manufactures cardiac devices.

In a press release issued on 29 February 2013, the company said FDA had identified a number of deficiencies, including those related to 21 CFR 820, which encompasses the quality system regulations for medical devices. Edwards said its design validation, process validation, corrective and preventive action (CAPA) processes, finished device acceptance and packaging processes were all flagged by FDA as being inadequate.

Edwards noted the inclusion of a relatively common clause in the Warning Letter which explained that FDA will not approve any premarket submission reasonably associated with the quality deficiencies identified at the plant.

"We are committed to thoroughly addressing the issues identified with the quality systems for our CSS devices, and have already initiated responses to address FDA's observations," said Michael Mussallem, Edwards' chairman and CEO, in the statement. "Our first priority is delivering quality, life-saving devices to patients."

Hospira

Hospira took a less direct approach to publicizing its receipt of the Warning Letter, alerting investors to its existence in a Form 8-K financial update on 29 May 2013, but unlike Edwards published the contents of the entire letter.

In the company's 8k statement, it said its Irungattukottai, India facility had received a Warning Letter based on an October 2012 inspection by FDA.

That letter goes on to note "significant violations" of current good manufacturing practices (CGMPs) for finished pharmaceuticals (21 CFR 210 and 211). Those allegations include unsanitized surfaces and unsanitary practices. Those observations were similar to ones seen at the company's North Carolina manufacturing facility as well, FDA added, requiring evidence that the company has a global corrective action plan in place.

In addition, FDA said it did not believe the company's facilities were adequate for the manufacture, process, packaging and holding of the drug products made at the facility. In one instance, holes were observed in a sterile circulation corridor; in another, the door to an aseptic area was observed to allow airflow between areas.

As with Edwards' letter, FDA wrote that the violations could be cause enough for it to withhold approval of any new applications or supplements listing Irungattukottai as a place of manufacture. Failure to correct the deficiencies could also be cause to deny entry to products manufactured at the plant, FDA added.

The company was given 30 days-an unusually long amount of time-to correct the alleged deficiencies.