From the Experts Blog - Montrium

Articles from Montrium's Expert Professional Services team!

Clinops

Reviewing the FDA’s Database of Inspectional Observations (Form 483) can be helpful when preparing for regulatory inspections. The database can provide insight into the FDA’s approach to inspections. It can also help in identifying your organization’s strengths and potential weaknesses from a regulatory standpoint.

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Where do Annex 11 and Part 11 intersect?