Manostaxx made a statistical analyze of FDA warning letters between 2018 and 2023. Graph below with top 18 areas with more warning letters issued:
Family smoking prevention and tobacco control is the area with more warning letters issued, followed by Unapproved new drugs.
Third position is for cGMP Finished products adulterated and in third Adulterated products related to coronavirus.
Important to notice, Foreigner supplier, seafood, Compounding pharmacy, API and unapproved opioids are in the TOP 18.
And Unapproved New Drugs / CBD products is in the 12th position.
Warning Letters
Chapter 4-1-1 of the RPM, on Warning Letter Procedures states “When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration’s (FDA) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. (Prior notice is discussed in Chapter 10 of the Regulatory Procedures Manual. The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law.
The agency position is that Warning Letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act).”
Consistent with Chapter 4-1-13 of the RPM on Freedom of Information, all FDA-issued Warning Letters (redacted) should be posted on FDA.gov to permit the public to obtain a copy directly without the need to submit a formal FOIA request.
Source of data: FDA
