Investigations operations manual 2017 fda

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The Contractor should also refer to the Investigations Operations Manual for guidance (Attachment 5). Page 18. FDA -- 2017 - MEDICAL DEVICES TEXAS. HOW FDA PREPARES FOR INSPECTIONS The FDA's Investigations Operations Manual Effective August 25, 2017, FDA issued Staff Manual Guide (SMG) 9004.1 toThe FDA Investigations Operations Manual (IOM) is the primary source of agency policy and procedures for FDA field investigators and inspectors and directs the Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of