An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS DRAFT NOTICE NO. 21-03

TO: Biologics Licensees, Permittees, and Applicants

 Directors, Center for Veterinary Biologics

 Veterinary Services Leadership Team

FROM: Byron Rippke

 Director

SUBJECT: Issuance of Inspection Certificate

I. PURPOSE

This Notice informs regulated entities of the new process for Issuance of Inspection

Certificates. Inspection certificates will be issued for in-depth inspections of U.S.

Veterinary Biologics Establishment Licensed sites. 

II. BACKGROUND

Veterinary Services (VS) Memorandum 800.91 was updated on December 11, 2020,

to include the issuance of Inspection Certificates. These certificates are issued to 

indicate the manufacturing site or sites have been inspected under U.S. laws and 

determined to comply with USDA’s good manufacturing practices (GMP). 

III. POLICY

A. Issuance of Inspection Certificates

1. Inspection Certificates will be issued for in-depth inspections for 

domestic sites (Licensees).

a. All sites visited during the inspection will be listed on the 

certificate. 

b. Inspection Certificates will not be issued for U.S. quarantine 

sites for permitted product. 

2. The Inspection Certificate will be digitally signed and sent back to the 

liaison for the Establishment via the NCAH Portal in the same Mail 

Log Item as the inspection report for the site. 

3. No additional copies of the Inspection Certificate will be granted for 

the site inspection. Attestations of GMP may still be requested as 

indicated in VS Memorandum 800.52. 

B. Issuance of Retroactive Inspection Certificates

1. Due to Covid-19 travel restrictions, in-depth inspections of licensed 

establishments have been postponed and the practice of issuing 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS DRAFT NOTICE NO. 21-03

Page 2

 An Equal Opportunity Provider and Employer

Inspection Certificates based on a current in-depth inspection has not 

been initiated. 

2. Issuance of an Inspection Certificate based on the last in-depth 

inspection conducted at the establishment site can be requested by the 

U.S. Veterinary Biologics Establishment Licensee. 

a. Request the Inspection Certificate through a formal submission 

via the NCAH Portal.

b. Use Submission Type – Inspection.

c. Enter Establishment Site and, if needed, Additional Sites for 

which the certificate is requested.

d. The Brief Description should indicate “Request for Inspection

Certificate”.

e. Enter the Mail Log Item listing the in-depth inspection report 

the certificate will reference.

3. No Inspection Certificates will be issued for inspection of foreign 

manufacturing sites for permittees or for the related quarantine site 

located in the United States. 

4. These certificates are valid for five years from the date of the initiation 

of the on-site inspection.

IV. IMPLEMENTATION/ APPLICABILITY

This change will be effective immediately. Once an on-site inspection has been 

conducted for a site, the option to request issuance of a retroactive Inspection Certificate 

will no longer be available for that site.