UNCONTROLLED COPY

ICSOP0105.01

Page 1 of 8

United States Department of Agriculture

Center for Veterinary Biologics

Standard Operating Policy/Procedure

Compliance Policy for Issuing Regulatory Actions

Date: April 20, 2017

Number: ICSOP0105.01

Supersedes: New

Contact: Coyle, Daniel C., (515) 337-6178

Approvals:

/s/Steven A. Karli Date: 03May17

Steven A. Karli, Director

Inspection and Compliance

Center for Veterinary Biologics

United States Department of Agriculture

Animal and Plant Health Inspection Service

P. O. Box 844

Ames, IA 50010

INTERNAL USE ONLY

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the 

product by USDA and does not imply its approval to the exclusion of other products that may be 

suitable.

Entered into CVB Quality Management System

by: /s/Linda S. Snavely 11May17 

 Linda S. Snavely Date

 Quality Management Program Assistant
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 2 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

Table of Contents

1. Purpose

2. Background

3. Regulatory Action
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 3 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

1. Purpose

This document describes the policy for issuing regulatory actions under the authorities of title 9, 

Code of Federal Regulations (9 CFR), parts 105.1(b), 105.2 and 105.3.

2. Background – Infraction

An infraction is considered a violation of the law falling under the administrative law legal 

category. An infraction is an intentional or unintentional breach from the requirements. Any 

violation of the Virus-Serum-Toxin Act or 9 CFR could be ruled as an infraction. Whereas any 

violation of the rules and regulations could be considered an infraction, the Center for Veterinary 

Biologics-Inspection and Compliance (CVB-IC) must use its scientific judgment and regulatory 

discretion to evaluate how each violation has or may affect, either directly or indirectly, the 

purity, safety, potency or efficacy of the veterinary biological product throughout the shelf life 

(expiration dating) of the product. 

The January 18, 2011, Presidential Memorandum regarding Regulatory Compliance directs 

Agencies on how they should view regulatory compliance.

Greater disclosure of regulatory compliance information fosters fair and consistent enforcement 

of important regulatory obligations. Such disclosure is a critical step in encouraging the public 

to hold the Government and regulated entities accountable. Sound regulatory enforcement 

promotes the welfare of Americans in many ways, by increasing public safety, improving 

working conditions, and protecting the air we breathe and the water we drink. Consistent 

regulatory enforcement also levels the playing field among regulated entities, ensuring that 

those that fail to comply with the law do not have an unfair advantage over their law-abiding 

competitors. Greater agency disclosure of compliance and enforcement data will provide 

Americans with information they need to make informed decisions. Such disclosure can lead the 

Government to hold itself more accountable, encouraging agencies to identify and address 

enforcement gaps.

The Memorandum further directs Agencies to formulate the disclosure of such regulatory 

actions. Agencies with broad regulatory compliance and administrative enforcement 

responsibilities... to the extent feasible and permitted by law, shall develop plans to make public 

information concerning their regulatory compliance and enforcement activities accessible, 

downloadable, and searchable online.

9 CFR 105.2 describes the authority to notify the licensee of an infraction of a requirement of a 

product license.

a. Two elements must be substantiated:

i. The infraction as it relates to the Product Code (product license).

ii. The part, and if applicable, section of 9 CFR that was violated.
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 4 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

b. Notification to the licensee/permittee

i. An infraction is written after all the evidence is gathered; there is no 

timeline on infractions. Other regulatory actions may be needed prior to 

the infraction to address the issue.

ii. Only the Compliance Section Leader or Compliance Manager or another 

IC Sectional Leader or Director may sign an Infraction Notice Letter 

according to the delegation of authority, ICSOP0001, Delegation of 

Authority for Center for Veterinary Biologics-Inspection and Compliance.

The CVB usually becomes aware of an infraction by:

c. The firm notifies CVB of the violation.

d. The CVB discovers the violation.

i. Through review of correspondence.

ii. Through inspection activities.

iii. Through Pharmacovigilance activities.

Background – Market Suspension

9 CFR 105.3 describes the process CVB will use to informally suspend an establishment license, 

product license, or permit. 

9 CFR 105.3: If at any time it appears that the preparation, sale, barter, exchange, shipment, or 

importation, as provided in the Virus-Serum-Toxin Act, of any biological product by any person 

holding a license or permit may be dangerous in the treatment of domestic animals, the 

Secretary may without hearing notify the licensee or permittee..........

Also, a product may be found to be worthless, contaminated, dangerous or harmful if:

1. The construction of the establishment in which the biological product is prepared is 

defective, or the establishment is not conducted as required by the regulations in 9 CFR 

101 through 118.

2. The methods of preparation of the product are faulty, or the product contains impurities 

or lacks potency.

3. The product is labeled or advertised as to mislead or deceive the purchaser in any 

particular.

4. The licensee, permittee, or the foreign manufacturer has failed:

a. To maintain and make available for inspection, records in connection with the 

development and preparation of product, or has failed to provide complete and 

accurate information when requested.
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 5 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

b. Has failed to provide complete and accurate information in the Outline of 

Production, or in reports and records.

5. The licensee or permittee has violated or failed to comply with any provision of the 

Virus-Serum-Toxin Act or the regulations.

6. The license or permit is otherwise used to facilitate or effect the preparation, sale, barter, 

exchange, shipment, or importation, contrary to the Virus-Serum-Toxin Act, of any 

worthless, contaminated, dangerous, or harmful biological product.

7. As described in Veterinary Services Memorandum No. 800.57, any product not made 

according to the filed Outline of Production may be worthless, contaminated, dangerous 

or harmful. A product not made according to the Outline of Production, or Special 

Outline, is considered worthless and harmful, and may be contaminated or dangerous 

until proven otherwise.

NOTE: “Harmful” is interpreted by the CVB to be harmful to the animal OR harmful to 

the environment OR to the general public interest or welfare.

3. Regulatory Action

I. All violations must be assessed to determine severity and risk. All violations may 

affect the quality of the product and the control of the manufacturing processes and 

the facilities. 

II. Previous violations in relationship to the current matter must be evaluated. 

a. Certain aspects of the previous violation contribute to the final decision 

regarding the current violation. 

b. Any previous violation or regulatory action, whether the action was initiated by 

the firm (Voluntary Stop Distribution and Sale) or by the CVB is an indicator of 

a lapse of control in the manufacturing process and may have affected, directly 

or indirectly, the quality of the products or products manufactured. 

c. Some of the factors that contribute to escalating the type of regulatory action:

i. A similar violation within the past three years.

ii. A similar violation within the same manufacturing area in the last three 

years.

iii. A similar violation regarding the control of the production process.
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 6 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

iv. A similar violation regarding the quality assurance process.

III. There are three types of violations. 

a. Minor

i. Minor violations, when assessed accurately are likely to have minimal risk 

to product quality. Thus having a minimal chance of affecting the quality 

of the product. This type of violation may also indicate laxity or error in 

manufacturing control that could become more serious if not corrected. 

ii. If numerous minor violations are noted during an inspection, during an 

investigation, or other avenue, it is indicative of poor management, lack of 

manufacturing control and should be considered as having a cumulative 

effect and be of a higher risk.

iii. A Letter of Advice may be imposed.

iv. Examples: 

1. Minimal non critical record keeping error or errors (part 116) –

Letter of Advice

2. The submission of an incorrect serial number on the APHIS Form 

2008 subsequently identified by the firm prior to distribution of the 

product (part 116) – Letter of Advice

b. Less Serious 

i. Less serious violations, by repetition or very nature, may affect the quality 

of a product, numerous products or manufacturing processes.

ii. These violations may require further evaluation before the final regulatory 

action is taken by the CVB.

iii. Holding release of serials or products through a Hold Release may be 

required.

iv. A Letter of Advice or Infraction Notice may be imposed.

v. Examples

1. Expiration of Reference prior to use for serial release testing 

(future serials) – Hold Release

2. First violation of a non-critical nature with the appropriate root 

cause and corrective action identified
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 7 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

3. Multiple record keeping errors throughout the manufacturing (part 

116) – Infraction

4. An APHIS Form 2008 has been submitted to the CVB for 

consideration for release of a serial and the firm finds that the 

Outline of Production/Special Outline was not adhered to. The 

product had not been released for marketing. The expectation is the 

manufacturer has reviewed the serial for quality and has committed 

that it is ready for release. – Infraction.

NOTE: It is the expectation of the CVB that the licensee/permittee has 

assured that the product was manufactured according to the Outline(s) 

and regulations prior to submission of an APHIS Form 2008. 

c. Serious

i. Violations of this degree may affect the quality of the product or numerous 

products. A Hold Release or APHIS Mandated Stop Distribution and Sale 

should be imposed until a full risk assessment can be performed by both 

the licensee/permittee and the CVB.

NOTE: An APHIS Mandated Stop Distribution and Sale cannot be 

imposed by the Biologics Specialist during inspection until approved 

by an IC Section Leader or IC Director at the CVB.

ii. Regulatory actions that may take place: 

1. Hold Release

2. APHIS Mandated Stop Distribution and Sale

3. Infraction Notice (post evidence gathering)

iii. Examples:

1. Failure to perform ingredients of animal origin testing (part 

113.53) – Hold Release or Mandated Stop Distribution and Sale

2. Use of a media, that has not undergone growth promotion testing, 

for serial release testing and the subsequent submission for 

consideration for release or marketing release of the serial (part 

113.25) – Mandated Stop Distribution and Sale

3. The Biologics Specialist finds (usually during an inspection) that 

the Outline of Production was not adhered to during the 

preparation of a serial and the serial was released for marketing by 

the CVB (Part 102.5). – Mandated Stop Distribution and Sale
Center for Veterinary Biologics ICSOP0105.01

Standard Operating Policy/Procedure Page 8 of 8

Compliance Policy for Issuing Regulatory Actions

UNCONTROLLED COPY

4. Not adhering to the Product License or Permit Restriction – 

Infraction

5. The licensee/permittee finds that the Outline of Production was not 

adhered to during the preparation of a serial and the serial was 

released for marketing by the CVB.

a. If the firm provides reasonable investigative assurance that 

there was an unlikely affect to product quality from 

marketing release to expiration – Infraction Notice

b. If the firm does not provide reasonable investigative 

assurance that there was an unlikely affect to product 

quality or does not take the action of a Voluntary Stop 

Distribution and Sale action – Mandated Stop Distribution 

and Sale

IV. All violations should require an action by the licensee or permittee. Depending on 

the severity of the violation, a root cause analysis and corrective/preventive action 

should be performed by the licensee/permittee. The actions taken by the 

licensee/permittee to adequately address the violation may require review and 

comment by the Biologics Specialist. 

Note: The assessment of the product passing Section V testing as the only 

scientific evidence the product quality has not been affected is insufficient 

investigative assurance.

V. Failure of a licensee or permittee to appropriately address the violation with 

evidence that the licensee or permittee is preparing and distributing product 

contrary to the Virus-Serum-Toxin Act would require the procedures addressed in 9 

CFR 105.1 (a) be executed.