Animal Health
Inspection and Compliance |
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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.
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.
- 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.
- 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.
- Investigations: Investigations of alleged violations of the Act or regulations are conducted or directed by trained CVB investigators.
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Last Modified:
July 6, 2007