Recipient: Shelhigh Inc.Product: Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits and other devices Date:12/14/05 Failure to obtain premarket approval prior to offering products for sale; failure to follow written procedures for design control; failure to follow written procedures for design validation to include a risk analysis; failure to validate corrective and preventive...Read More

Recipient:Rite-Dent Manufacturing CorpProduct:Alginate impression material, zinc phosphate cement, polycarboxylate cement and other dental OTC devices Date: 12/2/05 Your firm failed to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose(s) and is capable of producing valid results. Each manufacturer shall maintain...Read More

Recipient: LifeScan Inc.Product: OneTouch Ultra and OneTouch UltraSmart Blood Glucose Readers Date: 12/7/20055 Your October 6, 2005 response also describes the need to validate changes planned for your electronic complaint handling system. Again, a timeline for the completion of your validation study was not provided. The validation of your complaint handling system and the training...Read More