The Director, CVB-Inspection and Compliance (CVB-IC) has been delegated the authority to direct the inspections of licensed establishments, prospective licensees, foreign manufacturers, and recipients of imported biological products under the Virus-Serum-Toxin Act. The CVB-IC Team Leaders, Senior Biologics Specialists and Biologics Specialists (hereafter called the Specialist) plan, schedule, and conduct the inspections with the support of the Biologics Compliance Assistants (BCAs).
Each inspection is one of three types (Reference: VS Memo 800.91) (PDF 46KB):
- An in-depth inspection is an unannounced, detailed inspection in which overall compliance with regulations and other requirements is systematically examined. The size of the plant, the number of inspectors on the inspection team, and problems encountered determine the length of time expended at the establishment. As many inspection categories as possible are examined.
- Follow-up inspections are conducted to determine if corrections required as a result of a previous in-depth (or follow-up) inspection have been made. Need for a "follow-up" and length of time for the inspection are determined by the Specialist, based upon the nature of the corrections required.
- A special inspection is any inspection not of the previous two types. This type of inspection is requested in writing by CVB-PEL personnel or other Government officials, or is directed by the Director, CVB-IC. Examples of special inspections include:
- Pre-licensing facility inspections
- Select agent inspections
- On-site product inspections (e.g., field trials, efficacy studies, duration of immunity studies, and bench record review)