February 23, 2001
483Company: Eli Lilly & Company City and Sate: Indianapolis, IN FDA District: Detroit, MI Dates of Inspection: 1/29-2/9, 21, 22, 23/01 18. SOP #001-001757 “Process Control System Security” is used as a global document to describe the guidelines for maintaining the security of the process control systems and related documents for Parentaeral Products Operations. However,...
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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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