When the U.S. Food and Drug Administration (U.S. FDA) finds that a company has significantly violated its regulations, the agency notifies the manufacturer in the form of a Warning Letter.
- Failure to promptly correct violations and respond in writing within fifteen (15) working days may result in legal action by FDA without further notice, including seizure and/or injunction.
- Your response should outline the specific actions you are taking to address these violations and to prevent similar violations from occurring in the future.
- You should include in your response documentation and any other useful information that would assist the FDA in evaluating your corrections.
- If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
The U.S. FDA’s practice is to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates a recall, seizure, injunction, administrative detention, civil money penalties and or prosecution.
If the Warning Letter is to a foreign food facility, FDA will contact the U.S. Agent by email, phone, facsimile, or regular mail within 5 business days and inform the agent that a redacted letter is available on the Warning Letter page.
A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act. Such letter is posted publicly on www.fda.gov.
However, the FDA is under no legal obligation to warn individuals or firms that they or their products are in violation of the law before taking enforcement action, except in a few specifically defined areas.
When acting under the authority of the Electronic Product Radiation Control Provisions of the Federal Food, Drug, And Cosmetic (FD&C) Act, the FDA is required by law to provide a written notification to manufacturers when the agency discovers products that fail to comply with a performance standard or that contain a radiation safety defect.
A Warning Letter is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.
Expect Warning Letters to request the recipient cease any violative conduct listed below. This list is not exhaustive:
▪ Unapproved New Drugs.
▪ Misbranded New Drugs.
▪ Misbranding of an Investigational New Drug.
▪ Omission of Risk Information.
▪ Omission of Material Fact.
▪ Adulterated Dietary Supplements.
▪ Misbranded Dietary Supplements.
▪ Failure to
- maintain Current Good Manufacturing Practices.
- properly maintain equipment used in the manufacture of API.
- conduct Hazard Analysis and Risk-Based Preventive Controls.
- update drug listing files to reflect discontinuance of drug products.
- submit under Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use).
Your drugs could be adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, it may recommend withholding approval of any new applications or listing.
Furthermore, your drug products could be misbranded in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered, and the articles have not been listed as required.
Labeling misbrands a product if:
- It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count
- There is any representation that creates an impression of official approval because of the possession by the firm of an FDA registration number
- The labeling lacks adequate warnings for the protection of users, and there is potential for adverse events associated with the use of this product, particularly since someone who takes it would be unaware of the presence of the undeclared ingredients
- You sell products that are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people, without FDA approval, clearance, or authorization
If your company is not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of admission if they are offered for importation into the United States.
FDA could recommend engaging a third-party consultant qualified to evaluate your operations to assist your firm in meeting CGMP (Current Good Manufacturing Practices) requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP.
The U.S. Food and Drug Administration may also advise the appropriate regulatory officials in the country from which you operate that it considers your product(s) listed to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
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