9 CFR § 105.2
Notification of infractions
November 6, 2020
If an infraction of a requirement of a product license is brought to the attention of the licensee by written notification thereof by Animal and Plant Health Inspection Service, a subsequent violation of similar nature occurring with the same licensed biological product within 6 months of the said written notification shall be primafacie evidence of willful violation and the license for the product shall be subject to suspension or revocation under the provisions of §105.1(b).
[42 FR 31430, June 21, 1977, as amended at 56 FR 66783, Dec. 26, 1991]