Definition

An official FDA communication citing significant regulatory violations that must be addressed to avoid further enforcement action.

Example

FDA warning letter cites: 'Failure to submit 15-day reports for serious, unexpected adverse reactions as required by 21 CFR 314.80(c)(1)(i).'

Regulatory source

FDA Enforcement

Common mistakes

Not treating warning letters with appropriate urgency or providing inadequate response.

Inspector question

How would your organization respond to a warning letter? Who would be involved?

Related terms