Day

June 23, 1999
Solvay Pharmaceuticals 6/23/99 Computer System Validation 1. The xxxx computer system, used to monitor and maintain such critical systems as the xxxx and xxxx systems, has not been validated. Our inspection revealed that the xxxx computer system is used to monitor temperature, conductivity, water pressure and time (in hours) for replacement of xxxx for the...
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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:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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