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Pharmaceuticals / Quality / Regulatory Affairs / GMPs / Inspections and Audits

Indian Hospira Plant Gets Form 483 With 23 Observations

Dec. 30, 2013

Long-embattled sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, manufacturing plant.

Hospira promised in May to address the FDA’s concerns about its plant, as well as to create the global corrective action plan mandated in the warning letter that followed the 2012 inspection.

The observations listed in the fresh Form 483 relate mainly to processes and procedures, according to an SEC filing. Hospira says it takes this matter seriously and intends to respond fully in the coming weeks. A disruption in production is not anticipated, the drugmaker adds.

In the wake of those revelations comes more bad news from Hospira as it now finds itself recalling one lot of certain single-dose vials of lidocaine HCl injection, USP, according to an FDA safety alert published Dec. 23. The market correction was prompted due to a reddish-orange particulate on the inner surface of the vials and inside the solution itself, the agency says.

Hospira has a history of struggling with particulates in its products. Most recently, a July-to-August inspection of its McPherson, Kan., plant turned up glass in sterile lyophilized drugs.

But 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 last month.

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. — Lena Freund