FDA Warning Letters

The Significance of Warning Letters

FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters are common food, dietary supplements, cosmetics, drugs, medical devices, biologics (including clinical and pre-clinical research), veterinary medicine (food, supplements, drugs), and tobacco products (cigarettes and e-cigarettes).

The FDA views Warning Letters as serving two purposes. First it creates a record of the violation. This is known as “prior notice.” An accumulation of Warning Letters for the same or similar violations allows the Agency to quickly escalate the penalties imposed, including criminal prosecution. Second, the Warning Letter is a “non-final” recommendation intended to change a recipient company’s behavior. This is a bit misleading since Warning Letters are intended to impose changes beyond simple recommendations. The effect, however, is an non-judicially-contestable enforcement action. Hence the severity and importance.

Warning Letters are often used following facility inspections and Form 483. Form 483 is a list of Inspectional Observations. In short a list of violations found during an inspection. In some cases the violations are routine, but the response indicates a wider compliance problem leading the FDA to issue a Warning Letter. In other cases, the violations are too severe for a Form 483 which is not reviewed by Compliance or Center Directors prior to issuance. The Regulatory Procedures Manual includes a list of violations deemed inappropriate for a Form 483. Common Warning Letter topics include:

• Unapproved medical devices;
• OTC Drug Monograph deviations (claims, ingredients, indications for use);
• Unapproved veterinary drugs (often foods with therapeutic claims);
• Violations of Good Manufacturing Practices (GMPs or cGMPs);
• Violations of Good Laboratory Practices (GLPs);
• Unapproved dietary supplements;
• Unapproved food additives;
• Unapproved color additives;
• Violations of