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• Voluntary Recall on Honduran Cantaloupes Due to Potential Health Concerns

  - 2008-03-29

  WESTLAKE VILLAGE, Calif. -- Dole Fresh Fruit Company, a subsidiary of Dole Food Company, Inc., has voluntarily recalled all Honduran Cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras. This recall has been initiated based on current information from the U.S....

  Tags: FDA, Westlake

• Radiometer America, Inc., Westlake, OH, Oct. 12

  - 2007-01-16

  During a March 10, 13-16, 22-24, April 4-6 and May 3-5, 11, 12 and 23-25 inspection of the medical device manufacturing facility, FDA determined Radiometer America was not in conformance with the current GMP requirements of the QS, including correction and removal rules. Violations included, but were not limited...

  Tags: FDA, Westlake

• Natren, Westlake Village, CA, Nov. 21

  - 2006-12-01

  FDA objected to the company's website marketing of the products for human consumption--GyNa-Tren Vaginal Health Solution (Gy-Na-Tren) and Life Start--because the products were being promoted as drugs for which no NDA had been filed. Specific labeling statements on the aforementioned products to which the agency took issue included "clinically...

  Tags: Computer Associates International Inc., FDA, Westlake

• Radiometer America, Inc., Westlake, OH, Oct. 12

  - 2006-11-01

  During a March 10, 13-16, 22-24, April 4-6 and May 3-5, 11, 12 and 23-25 inspection of the medical device manufacturing facility, FDA determined Radiometer America was not in conformance with the current GMP requirements of the QS. Violations included, but were not limited to, failure to investigate complaints...

  Tags: FDA, Westlake

• Cosmetics

  - 2004-07-26

  13162W C & K Manufacturing & Sales Co., LLC, Westlake, OH, June 23 Cincinnati. FDA collected labels and promotional materials for the firm's DermCare AL Antimicrobial Lotion at a Nov. 25-Dec. 2, 2003, inspection. The agency objected to statements claiming the product "immediately kills pathogens" and that its "antimicrobial...

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• Westlake Village, Calif., Firm's Drink Offers Nicotine Alternative.

  - 2003-10-30

  By Brent Hopkins, Daily News, Los Angeles Knight Ridder/Tribune Business News Oct. 30--WESTLAKE VILLAGE, Calif.--Steve Reder hates cigarettes. A self-described "avid nonsmoker," he hates the smell and smoke of a smoldering butt. And now, he has an alternative for those ...

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• Columbia Mammography Center, Westlake, OH

  - 2000-01-17

  Columbia Mammography Center, Westlake, OH, Dec.13, 1999 Cincinnati. FDA cited Columbia for missing phantom QC records. A representative of the state of Ohio inspected the clinic on Sept. 28.

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• Dental/Medical Diagnostic Systems Inc. Announces That It Has Shipped 500 Units of the Apollo 95E Tooth Whitening and Composite Curing System Domestically Since It Received 510k Notification on Aug. 20, 1998

  - 1998-09-10

  WESTLAKE VILLAGE, Calif.--BUSINESS WIRE--Sept. 10, 1998-- Dental/Medical Diagnostic Systems Inc. (Nasdaq:DMDS) (Nasdaq:DMDSW) Thursday announced that is has already shipped 500 units of the Apollo 95E domestically since it received 510k notification for the Apollo 95E tooth whitening and curing system from the United States Food and Drug Administration FDA pursuant...

  Tags: FDA, Westlake

• Dental/Medical Diagnostic Systems Inc. Announces That It Has Shipped 500 Units of the Apollo 95E Tooth Whitening and Composite Curing System Domestically Since It Received 510k Notification on Aug. 20, 1998

  - 1998-09-10

  WESTLAKE VILLAGE, Calif.--BUSINESS WIRE--Sept. 10, 1998-- Dental/Medical Diagnostic Systems Inc. (Nasdaq:DMDS) (Nasdaq:DMDSW) Thursday announced that is has already shipped 500 units of the Apollo 95E domestically since it received 510k notification for the Apollo 95E tooth whitening and curing system from the United States Food and Drug Administration FDA pursuant...

  Tags: FDA, Westlake