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Inspection and Compliance Unit

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The Center for Veterinary Biologics (CVB) Inspection and Compliance (IC) unit 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

Our mission is to 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.

How We Assure Compliance

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 CVB in order for our 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/permittee's official liaison.

The Director of 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.

About Facilities Inspections
Each inspection is one of three types (reference VS Memo 800.91):

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.

Followup inspections are conducted to determine if corrections required as a

result of a previous in-depth (or followup) inspection have been made. Need for

a "followup" 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 CVB-IC Director. Examples of special inspections

include:

Prelicensing facility inspections

Select agent inspections

Onsite product inspections (for example, field trials, efficacy studies,

duration of immunity studies, and bench record review)

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 (CVB-PEL) unit, and each batch is approved or rejected by

CVB-IC for marketing.

Release of satisfactory veterinary biologics for marketing by licensees, the handling

of various requests from the licensees concerning biologics, and other related

necessary administrative tasks are handled by the CVB-IC in Ames, IA.

All licensees and permittees are required to submit an APHIS Form 2008 for each

serial or subserial which reaches any stage of identification and testing. CVB-IC

receives these forms and enters key information into a biologics database. This

information is used to ask the CVB-PEL for test information, to prepare the

semiannual publication on numbers of doses prepared and destroyed, and to

provide information for biologics specialists to use during inspections.
Serials found satisfactory, or those to be released without testing by the CVB-PEL,

are processed without delay by the biologics compliance assistants (BCAs). Serial

release is the top priority for the BCAs.

Adverse Event Reporting

The use and performance of veterinary biologics in the field are monitored through

analysis of adverse event reports received by CVB.

Learn more about adverse event reporting

Investigations

Investigation of alleged violations of the Virus-Serum-Toxin Act (VSTA) involving

veterinary biologics can be divided into three categories:

1. Violation of the VSTA by unlicensed manufacturer—This is the

preparation, sale, barter, exchange or shipment of products by a manufacturer

not licensed; the importation into the United States of an unlicensed product

intended for the treatment, prevention, or diagnosis of disease in domestic

animals; or the adulteration of licensed product by an unlicensed person.

2. Violation of the VSTA by licensed manufacturer—This includes illegal

movement of a known defective, licensed product or of an unlicensed product

produced by a licensed manufacturer; importation into the United States by a

licensed manufacturer of an unlicensed product intended for the treatment,

prevention, or diagnosis of disease in domestic animals; or a licensed

manufacturer making false or misleading claims about a licensed product.

3. Violation of regulations under the VSTA by licensed manufacturer—This

occurs when conditions found upon inspection of a licensed manufacturer are

not in accordance with 9 CFR Parts 101–118. Action may also be taken under 9

CFR Part 123.

Based on authority granted in the VSTA and regulations, CVB-IC takes appropriate

action based on findings from product monitoring, inspection, or investigations.

Recommendations for other actions are submitted to the CVB Director.