September 14, 2000
Oak Rubber Inc. 9/14/00 Examination gloves A failure to validate the manufacturing process and the computer system used to maintain the product inventory and shipping information. FDA New Orleans District SoftwareCPR Keywords: production software
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Crystal Medical Technology 9/14/00 Dental Implant Devices The inspection revealed deviations from Part 820 including failure to have a manufacturing validation study protocol and to validate software manufacturing equipment and the autoclave sterilization cycle, failure to conduct internal audits, incomplete Device Master Records and Standard Operating Procedures, no Design Plan, no change control procedures and...
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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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