ELM-104-12

Backdating Will Get You a Warning Letter from the FDA Really Quickly!

Another warning letter issued by the FDA because of backdating!

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sandoz-private-limited-445532-10222015

You don’t want this to be your company, do you?

Honesty is the Best Policy

Honesty is always the best policy.

If you forget to record something:

☑️ Enter the current date
☑️ Provide a brief explanation (with date of omission, description of why updating, sign / initial and date)
☑️ Never remove or obliterate any original data
☑️ Do not fabricate data or intentionally misrepresent it

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Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group