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The Pharma Marketing Glossary
An FDA Warning Letter is a correspondence that notifies a pharmaceutical or other FDA-regulated company about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act.
Where to find more information:
- Source: FDA Regulatory Procedures Manual March 2010 (pdf)
- Audio source: FDA BadAd Program