MDI and DPI Drug Products
...recommended for inclusion in the application regarding the components, manufacturing.....may have an effect on the quality and purity of valve components and, ultimately, 983.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...In MDI products, the container closure system consists of the container, the valve and its components.....The performance of the valve and its compatibility with other components of the drug.....The aerosol dispenser consists primarily of a metal or glass container, a valve assembly..
http://www.fda.gov/cder/fdama/difconc.htm (score=22)

ENFORCEMENT REPORT FOR MARCH 27, 2002
...REASON The recalled devices have internal stainless steel valve components that may..
http://www.fda.gov/bbs/topics/enforce/2002/ENF00736.html (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The dimensional measurements of metering valve components should be held to very tight.....The applicant should confirm the results by testing individual valve components from multiple.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The dimensional measurements of metering valve components should be held to very tight.....The applicant should confirm the results by testing individual valve components from multiple.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its..
http://www.fda.gov/cder/guidance/2180dft.htm (score=21)

PMA Final Decisions Rendered for May 2002
...Approval to transfer the manufacturing of the pyrolytic carbon coated heart valve components.....Also, removal of accessory components specified as Guide wire, Tunneling accessories and.....50 diopters (in both cylinder and sphere components) for at least one year prior to the..
http://www.fda.gov/cdrh/pma/pmamay02.html (score=21)

FDA Enforcement Report
...Premature wear to the internal valve components may cause detrimental leakage of pressure from.....Dual Cuff Control Valve, for activating air pressure to inflatable tourniquets used to.....Blood components, which were collected from a donor who had previously tested repeatably..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00012.html (score=21)

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