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Market Control

Inspections, Compliance, Enforcement, and Criminal Investigations

Our everyday efforts to keep you safe

 

Inspectorate Activities

The FDA is committed to safeguarding the safety of our food and the efficacy of medical products we depend on. Inspections play a vital role in this oversight, involving meticulous on-site evaluations to ensure compliance with federal regulations. However, inspections are one part of our multifaceted approach to ensuring the ongoing safety and quality of FDA-regulated items.

The FDA inspects the manufacturing and storage facilities of the below listed regulated products to ensure that manufacturing activities comply with the requirements of the current codes of Good Manufacturing Practices (cGMP) and storage and distribution conform to the requirements of Good Storage and Distribution Practices (GSDP).

  • Food
  • Allopathic medicines
  • Veterinary medicines
  • Vaccines and biological products
  • Herbal medicines
  • Homoeopathic medicines
  • Food supplements
  • Medical devices
  • Cosmetics
  • Household chemical substances

 

Enforcement Activities

Another aspect of the FDA’s multifaceted approach to ensuring the ongoing safety and quality of FDA-regulated items is Enforcement.

The Enforcement Directorate is a multi-disciplinary arm of the Technical Operations Division mandated to ensure compliance with the laws governing the regulation of FDA regulated products through investigation into malpractices and crimes, market surveillance and education. The Directorate relies on undercover personnel, confidential informants and sources as well as cooperating individuals to execute its mandate.

The Directorate ensures that FDA regulated products imported into the country or manufactured locally and distributed for sale and consumption by the public conform to applicable standards and are safe, efficacious, and of the right quality for use.

Activities include:

  1. 1. Initiation and monitoring of the recall of products which are found not to have met regulatory requirements or are non-compliant with set standards
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  3. 2. Sampling and testing, market surveillance, product quality monitoring and product verification done to ensure that counterfeit, falsified and unwholesome regulated products are prevented from entering the market or removed from the market to protect public health and safety
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  5. 3. Investigations into and prosecutions of all issues of non-compliance of regulated products
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  7. 4. Monitoring of advertisements of FDA regulated products to ensure compliance
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  9. 5. Raids and swoops in markets for non-compliant products
Forms and Guidelines