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Inspection and Compliance

The Center for Veterinary Biologics - Inspection and Compliance (CVB-IC) is responsible for developing and implementing programs to ensure veterinary biologics are prepared and distributed in compliance with the Virus-Serum-Toxin Act, and the regulations promulgated from it. The Act requires that both products and facilities be licensed, and products distributed in the United States must not be worthless, dangerous, contaminated, or harmful.

Mission

Ensure that veterinary biological products are produced and maintained in compliance with the Virus-Serum-Toxin Act.

Inherent within this mission are several fundamental concepts integrally associated with effectively achieving this charge. These include:

  • Serving agriculture, the public, agricultural organizations, the biologics industry, APHIS, and other Federal agencies, by facilitating communications and regulating the production and distribution of veterinary biological products.
  • Educating biologics manufacturers and users, and monitoring product performance, thus assuring the availability and proper use of veterinary biologics.
  • Creating an environment where all people are valued and everyone works together as a high-performing team.
  • Developing, maintaining, and using a diverse and high level of scientific knowledge.

 

Compliance is assured by:

  • Facilities Inspections: Periodic unannounced in-depth inspections of all licensed facilities are conducted by specialists trained in quality assurance inspections. Products imported from foreign countries must meet all U.S. standards, and foreign facilities are inspected at the same rate as domestic firms. Additionally, facilities are inspected prior to the issuance of an establishment license.

    • Administrative Inspection Review: The Administrative Inspection Review (AIR) is an annual review of all active licensees, all active permittees, and their records in comparison to the records kept at the Center for Veterinary Biologics (CVB) in order for CVB personnel to more effectively and efficiently enforce the Virus-Serum-Toxin Act and the pursuant rules and regulations. The review validates active licensees, active permittees, and their records concerning licensed premises, all responsible personnel, and production. The components of this review are specific to each licensee and permittee. It may include reports from CVB's databases, certified documents, and a generated AIR Worksheet of requested information about the licensee and permittee. These documents are authenticated by the licensee's/permittee's official liaison.

 

  • Product Inspections: Test results of every batch of veterinary biologic are submitted by the manufacturer for review. Results are compared with check testing conducted by the CVB's Policy, Evaluation, and Licensing unit (CVB-PEL), and each batch is approved or rejected by CVB-IC for marketing.
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  • Adverse Event Reporting: The use and performance of veterinary biologics in the field are monitored through analysis of adverse event reports received by the Center.
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  • Investigations: Investigations of alleged violations of the Act or regulations are conducted or directed by trained CVB investigators.


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Additional Information