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Compliance

FDA COMPLIANCE

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

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.

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.