Day

June 13, 1997
Metuchen Analytical, Inc. 6/13/97 Drugs 5. Lack of validation data to support the adequacy of the computer software (PC1000 version 2.5 supplied by [purged text] used to run the HPLC systems.
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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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