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Warning Letter
- - -
o cGMP enforcement
o Inspections
o Adulteration
o FDA 483
o Recall
o Warning Letter
o Border Alerts
o License Suspension or Revocation
o Seizure
o Consent Decree
o Criminal Prosecution

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A Warning Letter is a communication to the firm that has been reviewed within several levels of the FDA, including the district office and the Center at FDA's headquarters. The Warning Letter generally states that the firm has made products that are adulterated, violating the Food, Drug, and Cosmetic Act and that the firm has a very limited amount of time to address the problem(s) before the FDA takes further regulatory action against the firm, the adulterated product, and responsible individuals.

For example, FDA issued a Warning Letter to a firm in Illinois.

Responses to a Warning Letter (required by the FDA) are typically long, complex documents providing details and rationales for what the firm is planning to do. For example, here's Eli Lilly's 54-page response Portable Document Format to a warning letter.

Warning Letters are also used by the FDA to communicate to the broader industry what the FDA believes is essential for compliance. The agency publishes all Warning Letters at their website.
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