The FDA completed its latest Hospira site inspection with 23 cited "observations" regarding processes and procedures at the Irungattukottai, India, plant, according to regulatory filings. Hospira officials estimated that the FDA’s Form 483 citations wouldn’t impact its financial guidance for 2013.
"The company takes this matter seriously, and intends to respond fully, and in a timely manner," according to a Hospira filing. "The company does not anticipate that the Form 483 will have an adverse impact on the company’s ability to achieve the 2013 full-year financial projections communicated during the company’s 3rd-quarter 2013 earnings call, or on the costs to remediate this facility."
The citations are more bad news for Hospira’s India office, which earlier this year was the subject of FDA scrutiny. The FDA originally inspected the facility in October 2012, citing serious problems with workplace sanitation, product sterility and processing violations that meant the products coming out of that plant were considered adulterated under law. Hospira’s corrections failed to satisfy FDA concerns, and the agency issued another warning letter in May 2013.
Lake Forest, Ill.-based Hospira has been the target of several warning letters and facility inspections in recent years, including a 3-week inspection of a Rocky Mount, N.C., facility, which has been under the watchdog agency’s eye since an April 2010 warning letter.