Lawmakers probe FDA over handling of Cordis warning letter.(Regulatory...

Medical Design Technology;  September 1, 2007 ;     396 words ......Stupak, D-MI, refer to an April 2004 warning letter citing numerous manufacturing quality...stents and other vascular devices. The warning letter resulted from FDA inspections conducted...appropriately followed up on the inspection and warning letter in this case. In their letter to ...

Respironics Receives FDA Warning Letter Related to Carlsbad, CA Facility.

PR Newswire;  February 10, 2004 ;     409 words ......today announced that it received a warning letter from the U.S. Food & Drug Administration...company's Esprit(R) Ventilator. The warning letter follows an FDA inspection of manufacturing...was completed on June 27, 2003. The warning letter addresses specific observations made...

As I see it: Zantac warning letter is FDA's state-of-the-art. (warning to...

Medical Marketing & Media;  April 1, 1993 ;     700+ words ......the state of this art in a seven-page Warning Letter to Glaxo Pharmaceuticals, Inc., complaining...aspects of the promotion of Zantac. (A Warning Letter is a Kessler invention that merges...Adverse Findings. A key feature of the Warning Letter is its intention to be worrisome, not...

FDA issues warning letter to Boston Scientific.

Saint Paul Pioneer Press (St. Paul, MN);  September 8, 2007 ;     393 words ......Food and Drug Administration issued a warning letter last week to Natick, Mass.-based Boston...compliance in FDA's device divisions. The warning letter followed an inspection by the FDA's...acquisition of TriVascular. The August warning letter from the FDA comes as Boston ...

Pfizer gets its first GMP Warning Letter. (Washington Insider).(good...

Medical Marketing & Media;  April 1, 2002 ;     143 words ......practices compliance. A recent FDA Warning Letter details numerous significant deviations...Pfizer says this is the first-ever Warning Letter it has received due to drug manufacturing...the firm's quality control unit. The Warning Letter cited the plant's failure to follow...

Cyberonics Receives FDA Warning Letter Regarding the Good Manufacturing...

PR Newswire;  January 3, 2005 ;     700+ words ......today reported that it received a Warning Letter dated December 22, 2004 from the Dallas...District Office on November 9, 2004. The Warning Letter states that Cyberonics' responses are...issues identified in the letter. The Warning Letter will soon be available on FDA's website...

Guidant receives FDA warning letter about Minnesota facility

AP Worldstream;  December 28, 2005 ;     700+ words ......the Food and Drug Administration's warning letter Dec. 23, about three months after it...Edwards & Sons, said the FDA's warning letter had been anticipated by the investment...Guidant has 15 days from the date of the warning letter, sent Dec. 22, to update the agency...

FDA issues warning letter to Guidant

Deseret News (Salt Lake City);  December 28, 2005 ;     700+ words ......said Tuesday it received the FDA's warning letter Dec. 23, about three months after it...A.G. Edwards & Sons, said the FDA's warning letter had been anticipated by the investment...Guidant has 15 days from the date of the warning letter, sent Dec. 22, to update the agency...

Caraco Pharmaceutical Laboratories, Ltd. Responds to FDA Warning Letter.

PR Newswire;  November 25, 2008 ;     495 words ......submitted its response to the FDA warning letter that was received on October 31, 2008. In the warning letter, the FDA requested a response from...2008. As previously disclosed, the warning letter was issued as a follow up to the...

dp money: Warning letter.(Business)

Daily Post (Liverpool, England);  September 16, 2002 ;     22 words ...WORRIED about that endowment mortgage warning letter? IFA Promotion free endowment factsheet is available on 0800-085 3250 or www.unbiased.co.uk.

LaserSight receives warning letter from FDA, responds

Ophthalmology Times;  November 15, 2000 ;     194 words ...WINTER PARK, FL-LaserSight said it has responded to a warning letter it received from the FDA relating primarily to manufacturing...latter part of July. The audit was completed Aug. 2. In its warning letter of Sept. 28, the FDA asserted that certain aspects of LaserSight...

Warning letter issued based on seafood plant inspection.(Washington)(Brief...

The Food Institute Report;  August 8, 2005 ;     251 words ......July 19, 2005, FDA's Bothell, WA office issued a warning letter to the PACIFIC NORTHWEST BEST FISH COMPANY of Ridgefield...DONALD POPE VEAL FARM, Whitewater, WI received a warning letter from FDA because USDA reported the presence of illegal...

Guidant Gets FDA Warning Letter on Facility

AP Online;  December 27, 2005 ;     410 words ......Drug Administration sent the company a warning letter about unresolved problems it found...resolved, the company may receive an FDA warning letter or regulatory action. Guidant said...it will respond promptly to the FDA warning letter, and "believes that it can fully address...

Chronimed Acknowledges FDA Warning Letter.

PR Newswire;  March 24, 1999 ;     479 words ......acknowledged today that it received a warning letter from the Food & Drug Administration...Prairie, Minn. production facility. The warning letter , dated March 3, 1999, contends that...that took place in December of 1998. A warning letter is a written communication to a firm...

Flu Vaccine Manufacturer Receives FDA Warning Letter

Biopharm International;  August 1, 2006 ;     521 words ......Food and Drug Administration issued a Warning Letter to Sanofi Pasteur, Inc. (Lyon, France...deputy director of CBER, said the warning letter was issued to the manufacturer because...has 15 working days to respond to the warning letter. David Elder, director of the Office...