An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-06

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT:Virtual Inspections for Remodeled or New Facilities for 

Existing Licensed Establishments

I. PURPOSE

This Notice informs regulated entities of a new process for an option to 

perform an inspection of remodeled or new facilities used in the 

preparation of veterinary biological products. Inspections confirm the 

facility, equipment, personnel, and processes are acceptable for the 

purposes intended and a virtual inspection will assist with the 

continuity of business for currently licensed establishments. 

This is only to be implemented for existing establishments holding an 

unsuspended or unrevoked establishment license with the Center for 

Veterinary Biologics (CVB) and is not intended for prelicensing 

inspections of unlicensed establishments. CVB reserves the right to 

refuse to perform virtual inspections.

II. BACKGROUND

The current travel situation resulting from COVID-19 makes timely onsite inspections of remodeled or new facilities difficult. Due to 

restrictions on the market release of serials produced in unauthorized

areas, the investment made in a remodeled room or area, new building

construction, and/or acquisition of a new site may not be fully realized 

for product prepared for the marketplace prior to an on-site inspection. 

Title 9, Code of Federal Regulations, part 101.2 defines inspection as 

an examination made by an inspector to determine fitness of facilities 

and procedures used in connection with the preparation, testing, and 

distribution of biological products. Traditionally, the inspection has 

been performed on-site for remodeled, newly constructed buildings or a 

new site. 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
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 An Equal Opportunity Provider and Employer

The term “new construction” will be used in the remainder of this Notice and includes 

remodeled rooms/areas in current facilities, additions to current facilities, new building 

construction on currently licensed premises, and new sites not currently listed on an 

existing establishment license. 

III. ACTION

A. Licensee Pre-inspection Activities – This information may be submitted via the 

NCAH Portal

1. Inform CVB- Inspection and Compliance (IC) of the proposed new 

construction; this may include a preliminary drawing for review and comment

as noted in Veterinary Services Memorandum 800.78, Section V.F. This 

submission should include an overview of the project, including why the 

project is being done, what equipment is being moved or added, impact to 

other production areas, and the proposed timelines for milestones and 

completion of the project. CVB-IC will respond to the submission with 

additional requests related to the specific virtual inspection. The requests may 

include, but are not limited to:

a. A listing of critical equipment, new or moved, for the new construction 

and a statement affirming the equipment has been qualified and validated 

for the purposes intended. Any deviations or issues associated with the 

implementation of the equipment and how these issues were addressed 

should also be submitted.

b. A personnel list, including title and role, for those scheduled to perform 

functions in the new construction. 

c. A list of any products (antigens and/or serials) prepared at risk in the new 

construction post qualification and validation of the area. 

2. Submit completed facility documents for the new construction.

3. Submit a video of the finished new construction on a USB Flash Drive – this 

will serve as the initial tour of the area. The USB Flash Drive will not be 

returned. We recommend the video format be MP4 or MOV and keeping the 

file size to 35 MB or less. Depending on the size of the new construction, this 

may mean submission of several videos. Due to the constraints with the

NCAH Portal, this submission cannot be transmitted electronically at this 

time.

Mail this to: Attention CVB-IC, 1920 Dayton Avenue, Ames, IA 50010. 

The video should address the following points: 
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 An Equal Opportunity Provider and Employer

a. Include the room number prior to entering each room;

b. Include the unique equipment identification for all critical equipment in 

place;

c. Equipment operation, such as a fill line, may be included;

d. Capture all aspects of the room including floors (ie. drains, outlets), walls, 

and ceilings (including HEPA filters, air supply and returns, plumbing and 

electrical penetrations, and materials used in construction);

e. Demonstrate personnel and material flow.

Editing may be done to provide a more concise tour, but should not omit critical 

information. Include a statement in the cover letter that the video depiction is true 

and accurate and include the date the video was recorded.

B. CVB Inspection Activities

1. CVB will review the submitted information, comparing the video to the 

submitted documents. 

2. Additional information may be requested for review, including live video

and/or pictures. The additional information may include the following:

a. Qualification and validation summaries for specific areas and/or 

equipment. The validation should encompass the range at which the 

equipment will be used and demonstrate consistent quality. 

b. Training records for select employees. 

c. Production records for particular antigens and/or serials. 

3. Any violations noted or actions required will be communicated to the Liaison 

through a conference call, similar to an on-site closing meeting.

C. CVB Post-inspection Activities

1. A written field inspection report will be provided to the entity. 

a. The report will detail any actions required prior to use of the new 

construction.

b. If facilities, equipment, processes, and personnel were found acceptable, 

permission to use the new construction will be granted in the report.
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 An Equal Opportunity Provider and Employer

c. Products manufactured at risk post qualification and validation may not 

be eligible for release if issues are found. 

2. Facility documents will be processed, filed (if acceptable), and returned. 

Acceptable facility documents must be on file with CVB prior to 

consideration of release for products prepared in the new construction.

3. CVB may require notification of initial serials prepared in the new area when 

products are submitted for consideration for market release. These serials may 

be tested by CVB as a part of the consideration for market release. 

4. The special inspection performed by virtual means has the same regulatory 

outcome as an on-site inspection. Special attention will be given to the new 

construction at the next in-depth inspection and if needed appropriate 

regulatory actions will be taken at that time. 

IV. IMPLEMENTATION/ APPLICABILITY

This practice goes into effect immediately.