The QMN Weekly Bulletin

Hospira Rebounding as Rocky Mount Remediation Wraps Up

Nov. 15, 2013

More than three years after Hospira’s Rocky Mount, N.C., plant was warned for lax quality control, prompting a painful manufacturing slowdown and a costly remediation, the drugmaker expects to near the “top end” of production capability in 2014, Hospira’s chief said Nov. 6.

Company-wide remediation efforts have cost the generic injectable drugmaker $458 million since it was first warned by the FDA in 2010 for particulate contamination problems. Since then, it has struggled with shortages as it labored to maintain scaled-back production under the scrutiny of third-party auditors.

In 2013, the company is posting quarterly revenue increases again, and a recent inspection of Hospira’s Lake Forest, Ill., facility resulted in no Form 483, Hospira CEO Michael Ball said on a conference call.

Production at Rocky Mount has been steadily ramping up and revisions to its quality system to improve its investigations capacity are now at a point where sustainable compliance can be assured in the eyes of third-party auditors, he added.

Some less significant manufacturing deficiencies continue to trouble the drugmaker, however. In August, it received a three-observation Form 483 at its Kansas plant. FDA investigators criticized the McPherson, Kan., facility for an inadequate response to finding glass particles in sterile lyophilized drugs. During the inspection of the facility, the agency found that inspections into the particles were conducted long after discovery.

For example, Hospira received a customer complaint in April and received a sample on May 20 but didn’t complete the investigation until June 24. Investigators also found that Hospira failed to classify glass particulates as a “critical defect” even though there is a potential for causing adverse health consequences, the form reads.

Ball said on the Nov. 6 call that the company responded with a corrective action plan and does not expect a warning letter.

Do you know how to navigate the FDA’s investigations process? You do now, with the Investigations Operations Manual 2013, your no-stops guide to getting by with the FDA. Order your copy today.