As we have mentioned in numerous issues of this Newsletter, there are many drug companies in other countries that are sometimes prohibited from sending pharmaceuticals to the U.S. due to quality issues; these may impact the safety of the products and cause patient harm.

An Import Alert informs the FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. These violations could be related to the product, manufacturer, shipper, and/or other information. DWPE allows the FDA to detain a product without physically examining it at the time of entry.

It should be added, the purposes of the Import Alerts are to:

• Prevent potentially violative products from being distributed in the U.S.
• Free-up agency resources to examine other shipments
• Provide uniform coverage across the country
• Place the responsibility back on the importer to ensure that the products being imported into the U.S. are in compliance with FDA laws and regulations

Import Alerts can be found on the following websites:

• By country: http://www.accessdata.fda.gov/cms_ia/countryll-ist.html
• By industry: http://www.accessdata.fda.gov/cms_ia/industrycategory.html
• By number: http://www.accessdata.fda.gov/cms_ia/ialist.html
• By date: http://www.accessdata.fda.gov/cms_ia/iapublishdate.html

Next week, we will continue this series.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

FDA Catches China's Zhejiang Medicine Hiding Active Pharmaceutical Ingredient Test Data
The FDA has warned another Chinese drugmaker after finding it had been hiding batch test results that showed high peaks of out-of-spec readings. The FDA found that the employees routinely performed "unofficial analyses" that they kept out of the official quality-control records for its APIs. Some of the hidden records "displayed large unknown peaks that were not reported in the official records for the same samples," the FDA reported. And that, the agency said, could mean "the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs."
http://www.fiercepharma.com/manufacturing/fda-slams-china-s-zhejiang-medicine-for-hiding-api-test-data

European Medicines Agency Nails Artemis India Plant Over Simvastatin Active Pharmaceutical Ingredient Manufacturing Issues
Another API maker in India is in trouble over manufacturing issues; the Artemis Biotech plant in Hyderabad. The German drug authority did the legwork, leading to the recommendation that EU countries not accept the company's simvastatin APIs, plus the possibility its plant certification will be revoked. Among other issues, the authority reported a "demonstrated lack of QA oversight" including keeping important GMP data outside of the quality-management system, problems with data integrity, and conducting the plant's repackaging operations without any documentation and QA approval.
http://www.fiercepharma.com/manufacturing/ema-nails-artemis-india-plant-over-simvastatin-api-manufacturing-issues

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Did You Know ...

…that we can all be heroes in our own lives? The following is from Cowboy Ethics—What Wall Street Can Learn from the Code of the West (James P. Owen).

Tip of the Week

"You may feel that the Cowboy's Code does not fit our times, and it is true that few of us will ever be called to test our courage against perils anything like a raging blizzard or a runaway herd of cattle. But we can have the courage to give clients an honest account of bad news, or to confront a business practice that does not put the client first. Every time we make a decision, we can ask ourselves 'Is it right? Is it fair?'. We can decide that our honor and our reputations are not for sale. At a time when heroes are in short supply…

Looking Back

Doesn't kiss you,
Like she useter?
Perhaps she's seen,
A smoother rooster!!
     Burma Shave