The basic statute under which the federal government regulates foods, drugs, medicals devices and cosmetics is the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA). There have been numerous amendments to the statute, both expanding and contracting its reach, as well as court decisions that have changed the interpretation of the statutory language. FDA enforces the law through a variety of administrative actions and with the approval and assistance of the Justice Department, through judicial actions.

The agency is empowered to takes actions against products that are either “adulterated” or “misbranded” as defined by FDCA and against companies and individuals who cause products to become adulterated or misbranded. In addition to violations defined in the FDCA, FDA can define and establish requirements that are “binding” and have the full force and effect of law by promulgating regulations which are codified in Title 21 of the United States Code of Federal Regulations. FDA takes enforcement actions against noncompliance with the requirements using all appropriate legal means. CCS offers a range of regulatory compliance consulting and submission services including:

  • Developing and managing responses to List of Observations, FDA 483s, Untitled Letters and Warning Letters
  • Advice and assistance with development and implementation of Corrective Action Plans
  • Data Integrity Issue Resolution
  • FDA Regulatory Correspondence and Responses ∇
    • FDA 483 Responses
    • Warning Letters
    • Untitled Letters
    • Consent Decrees
  • Regulatory review of evidence ∇
    • FDA detentions
    • Civil seizure
    • Injunction actions
    • Consent Decrees
  • Representation at regulatory meetings with FDA (District Offices, Centers,ORA Enforcement

  • Regulatory Interpretations of FDA regulations and requirements
  • Resolving FDA detentions and refusals
  • Resolving Non-compliance Regulatory Issues<
  • Resolving Import Alerts Issues
  • Product Labeling Reviews and Revisions
  • Regulatory strategy development
  • Seminars and Training

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