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Australia packager gets FDA warning letter

13.06.2013

It’s not the heat, it’s the humidity, which FDA says made capsules brittle.

The heat in New Ryde, Australia, has put a local drug packager in hot water with the FDA. A warning letter has been issued to Contract Pharmaceutical Services of Australia, in the Sydney suburb. Before agreeing to install equipment to deal with humidity, the FDA found drug capsules and bulk ingredients that the agency believed were affected by the condition. Drug capsules were brittle, the FDA said, which might result in problems for patients. The company has installed new equipment to deal with humidity, but the agency also wants to know what it intends to do about drugs already shipped to the U. S. The warning letter comes even as the FDA is suggesting that drugmakers create quality agreements with contractors, including packagers, to delineate who is responsible for each aspect of quality in the process.

Source: fiercepharmamanufacturing.com


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