 |
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.
COMMAND SUMMARY
BEGIN 182
SELECT WARNING()LETTER?/ti,de
SELECT GUIDANT/CO
SELECT S1 AND S2
TYPE S3/6/1-5
TYPE S3/9/1
HOW TO...
1. BEGIN File 182 to search for FDA warning letters.
2. SELECT the type of document you want (e.g., warning letters) limited to the title and descriptors.
3. SELECT the company name limited to the CO field.
4. Combine the sets. |
?b 182
File 182:FDA News Mar. 2002-2006/Aug 24
(c) 2006 Washington Business Info.
Set Items Description
--- ----- -----------
?S WARNING()LETTER/TI,DE
1261 WARNING/TI,DE
377 LETTER/TI,DE
S1 201 WARNING()LETTER/TI,DE
?SELECT GUIDANT/CO
S2 337 GUIDANT/CO
?S S1 AND S2
201 S1
337 S2
S3 5 S1 AND S2 |
5. TYPE all records using Format 6 to see the company affected.
|
?T S3/6/ALL
3/6/1
0002224026 IBA397A90951211DA88DFB80B6A94E372 (USE FORMAT 7 FOR FULLTEXT)
Boston Scientific Stock Down Following Warning Letter ; May Compromise Guidant Deal
Friday, February 3, 2006
WORD COUNT: 357
3/6/2
0002223007 I661B3E90943511DAAE879FD61512DEDA (USE FORMAT 7 FOR FULLTEXT)
Guidant Says FDA Warning Letter Concerns Will Be Addressed
Thursday, February 2, 2006
WORD COUNT: 135
3/6/3
0002210019 I7CAFDA608A0511DAA6A48DD26C0F012F (USE FORMAT 7 FOR FULLTEXT)
Guidant Says FDA Warning Letter Concerns Will Be Addressed
Friday, January 20, 2006
WORD COUNT: 134
3/6/4
0002196008 I3B29CC507F0511DAABA2A52325C7F480 (USE FORMAT 7 FOR FULLTEXT)
Guidant Receives FDA Warning Letter; Plans to Respond Promptly
Friday, January 6, 2006
WORD COUNT: 283
3/6/5
0002187011 I07F5682077F411DA9088FE9670922424 (USE FORMAT 7 FOR FULLTEXT)
FDA RELEASES GUIDANT WARNING LETTER
Wednesday, December 28, 2005 WORD COUNT: 158 |
6. TYPE the desired record(s) using Format 9.
The record shows the company affected and the reason for the warning.
The entire warning letter can be seen at this Web site. |
?T S3/9/2
3/9/2
DIALOG(R)File 182:FDA News Mar.
(c) 2006 Washington Business Info. All rts. reserv.
0002223007 I661B3E90943511DAAE879FD61512DEDA (THIS IS THE FULLTEXT)
Guidant Says FDA Warning Letter Concerns Will Be Addressed
The GMP Letter, v1, n313
Thursday, February 2, 2006
JOURNAL CODE: THGL LANGUAGE: ENGLISH RECORD TYPE: FULLTEXT
DOCUMENT TYPE: Newswire
WORD COUNT: 135
TEXT:
Guidant said last month it is on track to address the FDA's warning letter concerns about a wide-range of current good manufacturing practice (cGMP) issues including electronic records and signatures. Guidant "believes it can fully address the concerns of the FDA without a material impact to its
business," the company said in a Dec. 27, 2005, statement. Guidant has made monthly progress reports to the agency in an attempt to address the agency's concerns.
The company's response came after a Dec. 22, 2005, FDA warning letter that told Guidant it had "failed to address all of the significant violations listed in the Form FDA-483." The FDA's inspection focused on quality systems in Guidant's Cardiac Rhythm Management (CRM) facilities in St. Paul, Minn. To view the warning letter, go to
http://www.fda.gov/foi/warning--letters/g5657d.pdf
http://www.fda.gov/foi/warning--letters/g5657d.pdf.
Copyright (c) 2006 GMP Letter
COMPANY NAMES: GUIDANT CORP
DESCRIPTORS: warning; FDA
DIALOG UPDATE DATE: 20060202; 17:36:14 EST
EVENT NAMES: MANAGEMENT PROCEDURES
INDUSTRY NAMES: COMPUTER SOFTWARE; CUSTOMER SERVICE; CUSTOMER RELATIONSHIP MANAGEMENT; MARKETING; GLOBAL MARKETING
SUPPLIER NUMBER: 5655.51398.a |
RELATED HOW DO I...? SOLUTIONS
NEED HELP?
Contact the Dialog Knowledge Center
Within North America 1 800 3 DIALOG (334 2564)
Outside North America 00 800 33 DIALOG (33 34 2564)
Web Form www.dialog.com/contacts/webform
|
You are viewing the
Click below to view the
 |
