June 3, 1997
Radia Industry Co. 6/3/97 Sterilization of plasma separators 1. Failure to conduct processing control operations in a manner designed to assure that the device conforms to applicable specifications, as required by 21 CFR 820.100(b)(2). For example, there was also an incorrect maximum conveyor speed observed on February 24, 1997, by the investigator and one member...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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