FDA Looks At Wrong Plant In China

[Guest guest]

FDA looks at wrong plant in China

NATASHA T. METZLER,

Associated Press Writer

Mon Feb 18, 5:39 PM ET

 

 

 

U.S. health officials evaluated the wrong factory when assessing the

safety of a Chinese-made drug ingredient that may be a source of

problems with a blood thinner, the Food and Drug Administration said

Monday.

 

Baxter International's heparin has been linked to four deaths and

hundreds of reports of allergic reactions. An investigation will take

FDA inspectors to China this week.

 

The Chinese manufacturer was not inspected because it was confused

with another company in the agency's database with a similar name,

said Joseph Famulare, deputy director of the Center for Drug

Evaluation and Research's compliance department. The FDA evaluated

that firm, which had a history of positive inspections and was not re-

inspected.

 

The agency discovered within the past month that the wrong factory

was evaluated, Famulare said, adding that as far as the FDA knows, it

is an isolated incident.

 

Investigators will travel to China this week to inspect the company

that produces the drug's active ingredient, according to Michael

Rogers, director of the division of field investigations within the

FDA's office of regulatory affairs. The team will include a chemist

fluent in Chinese and an expert in drug manufacturing technology.

 

" We've given this team the flexibility to extend this inspection as

long as it takes as well as investigate the appropriate leads within

China, " he said.

 

The agency doesn't know what is to blame for the deaths and allergic

reactions associated with Baxter's heparin.

 

Inspections are under way at a Baxter facility in Cherry Hill, N.J.

facility and at company supplier Scientific Protein Laboratories of

Waunakee, Wis.

 

Last week, the FDA told physicians to stop using Baxter's heparin,

citing 350 reports of side effects so far this year. In 2007, the

agency received 100 reports of problems with the drug. Baxter said it

would stop manufacturing multiple-dose vials while it and FDA

attempts to locate the source of the problems.

 

Baxter last month recalled nine lots of the injectable drug after

learning of allergic reactions among dialysis patients. The problems

included dizziness, fainting and a racing heartbeat.

 

The Associated Press.

Inc. All rights reserved.