FDA Enforcement and Compliance Manuals
Applicable Laws and Regulations
Hosting an FDA Inspection
FDA Inspection Guides
FDA Forms 482 and 483
Factors/Matters Leading to Warning Letters
The Common Deficiencies during FDA Inspections for Firms (Food, Devices, and Pharmaceuticals)
Establishment Inspection Reports (EIRs)
What to Discuss During Close Out Meeting at the End of an Inspection
How to Communicate Before, During and After FDA Inspection: Dos and Don’ts
Dealing with Warning Letters
Responding to 483s, if issued
FDA’s Warning Letter "Close-Out" Program
Consequences of Inadequate Corrections and Repetitive Violations
When FDA Issues a Close-Out Letter
Warning Letter Close-Out Timelines based on 32 Cases
Good Practices
When FDA Doesn’t Issue a Close-Out Letter

FDA Warning Letter Close-Out Program 2014

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