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FDA Inspection – A Survival Guide
Tutela Monitoring Systems LLC
While the FDA are the regulatory body, there is actually no legal requirement to respond to a Form 483 inspection report. According to the FDA’s own website, a form 483 report records “inspectional observations, and do not represent a final agency determination regarding your compliance.” It all sounds quite benign, but the consequences and ramifications can be serious and a timely, proper, ...
 
Vaccine Temperature Monitoring
Tutela Monitoring Systems LLC
ABC News recently reported (June 6 2012) that a new investigation by the Department of Health and Human Services' Office of the Inspector General (HHS OIG) found that many providers of immunizations don't store the vaccines at proper temperatures, potentially rendering them ineffective and placing children at risk for contracting serious diseases. Inspectors visited the offices of 45 providers in ...
 
California Transplant Donor Network
Tutela Monitoring Systems LLC
CaliforniaTransplantDonorNetwork/shortve rsion_Layout1 17/09/2014 15:20 Page1 California Transplant Donor Network (CTDN) is a non-profit organization that facilitates organ and tissue donations for transplantation in Northern and Central California and Nevada. CTDN works closely with hospitals, transplant centers, and the public making sure quality donations are provided safely and on time. CTDN ...
 
Tutela Monitoring Systems Document
Tutela Monitoring Systems LLC
Medline is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 350,000 products that serve the entire continuum of care. Medline products and programs can be found in most hospitals, extended-care facilities, surgery centers, physician offices, home care dealers, home health agencies and retail outlets. Medline leads the ...
 
CDC Sanitizing Guidelines
IT Medical Solutions
Summary of the CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 Note: All of IT Medical Solutions hardware solutions and equipment meet or exceed the CDC's Guidelines for Disinfection and Sterilization for non-critical equipment within healthcare facilities. This is accomplished by using antimicrobial equipment, mounts and rugged hardware that can withstand ...
 

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Tutela Wireless Temperature Monitoring Tutela Monitoring Systems LLC Tutela wireless temperature monitoring systems are fully FDA compliant, deliver unparalleled accuracy, and rock-solid audit trails for complete regulatory ...
 
Picaso Innovative Workflow Technologies, Inc. (Iwt) PICASO, IWT's nursing workflow enhancer reduces nursing documentation time by 40%. Watch how the intuitive touch screen, located at the patient's ...
 

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