ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA
WARNING
LETTERS
FDA COMPLIANCE EXPLAINED

When FDA finds that a company has significantly violated FDA regulations, it 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.

MOST FREQUENT VIOLATIONS

■ Unapproved New Drugs
■ Misbranded New Drugs
■ Misbranding of an Investigational New Drug
■ Failure to properly maintain equipment used in the manufacture of API
■ Omission of Risk Information
■ Omission of Material Fact
■ Failure to Submit Under Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use)
■ Failure to update drug listing files to reflect discontinuance of drug products
■ Adulterated Dietary Supplements
■ Misbranded Dietary Supplements
■ Failure to conduct Hazard Analysis and Risk-Based Preventive Controls
■ Failure to maintain Current Good Manufacturing Practices

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.

FDA COMPLIANCE

DETENTION
ASSISTANCE
OFFER

$350.00

LOW SERVICE FEE

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.

MISBRANDING

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 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.