Warning letter
In Oversight, quality & inspection
A warning letter is a formal notice from the FDA stating that it has found significant regulatory violations and requiring prompt correction. It normally asks for a written response within a short, stated period and is published on the agency's website. Failing to respond adequately can lead to further enforcement action.
Example
After an investigator fails to correct repeated consent and record-keeping problems raised in a Form 483, the agency issues a warning letter setting out the violations and a deadline to respond.
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