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| U.S. Food and Drug Administration "Import Alerts", Part 3 |
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This week, we will complete our short series on "Import Alerts" and look at interpreting them; explain what is a red, green, and yellow list; and give an example in the NEWS section below.
Interpreting Import Alerts
The following are the sections of the import alerts and their descriptions:
| Import Alert Number | | Number assigned by the FDA. First 2 numbers are the industry code to which it is assigned |
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| Published Date | | Last date it was updated |
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| Type | | Describes whether it is DWPE w/wo surveillance |
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| Import Alert Name | | Name of the alert/brief description |
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| Reason for Alert | | The purpose for which it was issued |
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| Guidance | | What actions the FDA may take and provide guidance |
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| Product Description | | Products subject to DWPE |
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| Charge | | Describes FDA laws/regulations applicable to the alert |
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| Countries | | Includes areas covered by the Alert |
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| List of Firms/Products on the Red List | | Lists of firms and/or products on the Red List and subject to DWPE |
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| List of firms/Products on the Green List | | Lists of firms and/or products on the Green List and not subject to DWPE |
Red, Yellow, and Green List
The following describes the three different Import Lists:
| Red | | Firms/products/countries are subject to DWPE |
| Green | | Firms/products/countries have met criteria to be exempt from DWPE |
| Yellow | | Firms/products/countries subject to intensified surveillance or firms that may have satisfied GMP issues but where the nature of violations may warrant further field examinations of individual entries and/or additional analyses |
Next week, we will start a new series looking at FDA Compliance Policy Guidelines (CPGs).
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
China Manufacturing Plant Full of Holes, Chipped Paint, and Insects
The Import Alert list has two plants added by the FDA that are operated by Xinxiang Tuoxin Biochemical in Xinxiang City, Henan, China. Inspectors looking the facilities over last year found buildings full of holes, insects flying in manufacturing areas, and equipment in total disrepair. The inspectors found non-dedicated drug manufacturing equipment "in a state of disrepair" with reactors that contained significant product buildup and chipped paint. The buildings were just as bad with chipped paint on the ceiling directly above open equipment used for manufacturing, gaps around windows and doors, holes in ceilings directly above equipment, and "lying insects that were observed in cleanrooms."
China now has 50% of the global active pharmaceutical ingredients market; exports of pharma products from Chinese companies to the U.S. grew 4% last year.
http://www.fiercepharma.com/manufacturing/fda-finds-china-manufacturing-plant-full-holes-chipped-paint-and-insects
China Drug Sales to U.S. Growing but with Safety Concerns
Chinese drugs and pharmaceutical ingredients worldwide jumped 3% to $56 billion last year. Pharma companies of China exports to the U.S. rose 4% last year. Also growing are questions about the safety of its products. Last year, about 700 Chinese firms were told by China regulators to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. About 75% were retracted by the manufacturers or rejected by Chinese officials.
China now has nearly 5,000 drug factories supplying the domestic market and more than 500 facilities registered to sell to the U.S. An example of the problem is when Chinese regulators arrived unannounced at the warehouses of a generic drug maker called Hainan Yier Pharmaceutical Co.; samples were taken and tests done. The results showed three batches of pharmaceutical ingredients intended for anti-depressant tablets didn't meet quality standards and were only a kind of starch. Some also contained poor quality ingredients.
http://www.bloomberg.com/news/articles/2016-08-29/questions-linger-on-china-drug-safety-even-as-sales-rise-in-u-s
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Did You Know ...
�that during the 3 � years of WWII, the people of the U.S. produced the following?
- 22 aircraft carriers
- 8 battleships
- 48 cruisers
- 349 destroyers
- 420 destroyer escorts
- 203 submarines
- 34 million tons of merchant ships
- 100,000 fighter aircraft
- 98,000 bombers
- 24,000 transport aircraft
- 58,000 training aircraft
- 93,000 tanks
- 247,000 artillery pieces
- 105,000 mortars
- 3,000,000 machine guns and
- 2,500,000 military trucks
And, that 16.1 million Americans in uniform in the various armed services accomplished the following?
- Invaded Africa
- Invaded Sicily and Italy
- Won the battle for the Atlantic
- Planned and executed D-Day
- Marched across the Pacific and Europe
- Developed the atomic bomb and, ultimately�
- Conquered Japan and Germany
http://csnbbs.com/thread-762400.html
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Tip of the Week
Our parents left us a great and productive nation. What are we going to leave to our children and grandchildren?
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Looking Back
It gave swell
Shaves before,
Now you'll like it
Even more!
The new--improved
Burma Shave
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