How Do I Find Warning Letter Announcements from the U.S. Food and Drug Administration (FDA) or The European Commission Issued in the Last Six Months?

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Find Warning Letter Announcements from the U.S. Food and Drug Administration (FDA) or The European Commission Issued in the Last Six Months?

TOPIC: Warning letters are very informative documents for monitoring FDA enforcement activities. For example, in the case of major problems with a medicine, especially those that may lead to death or serious injury, the FDA may require that a warning be placed on the drug's packaging. Warnings can provide vital background on violations observed during onsite establishment inspections, address issues like wording used in labeling and advertising, as well as the behavior of a company’s sales and marketing staff. These letters can affect a company’s reputation, stock value, and credit rating when customers, competitors, financial institutions, Wall Street and the press learn that problems exist.

Reviewing warning letters can help you keep up to date on the latest elaboration of regulatory guidelines and potential areas of vulnerability, in order to be prepared when scrutiny shifts to your company. In addition, they can also identify windows of opportunity in the marketplace while competitors cope with correcting violations. Warning letters are generally issued following an unsatisfactory inspection.

You can search for warning letter announcements in FDAnews (File 182). The notices provide the name of the company to which the warning was given, as well as the date of the warning and reason for it. You can find the complete letter at the FDA URL given in the record. FDAnews provides domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA) and The European Commission.

In this example you want to find a warning letter from the FDA issued to Guidant Corporation in the second half of 2005.

COMMAND SUMMARY

BEGIN 182
SELECT WARNING()LETTER?
SELECT PD=20050602:20051231
SELECT GUIDANT/CO
SELECT S1 AND S2 AND S3
Click S4 > Tasks > Picklist
Check records > select format

HOW TO...

1. BEGIN File 182 to search for FDA warning letters. 2. SELECT the type of document you want (e.g., warning letters) and the company name (/CO). Note: You can limit the document search to the title and descriptors. 3. SELECT a date range using publication date: PD=YYYYMMDD. 4. Combine the sets. 5. In the Set Links pane, click S4 > Tasks > Picklist to see the first 10 records in SHORT format (titles and descriptors).
6. Click the check box(es) for the records you want to see in more detail, select the Output/Format and click OUTPUT.
The record shows the company affected and the reason for the warning.
The entire warning letter can be seen at this Web site.

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Stock #: 53333; Last modified: 14 Sep 2011

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