Was a copy of the Feed Mill License (FML) and drug registration verified to be active and current?
References: • IOM 5.9.3– Medicated Feeds and Type A Articles • FD&C Act, – Section 501 • 21 CFR Part 510 – New Animal Drugs • 21 CFR Part 515 – Medicated Feed Mill License Example of a “needs improvement” rating: • The inspector failed to verify the firm’s medicated FML was current and active. • The inspector failed to verify the medicated feed manufacturer drug registration was current and active. • Is the firm required to be registered under Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and, if so, was the BT registration verified? References: • 21 CFR Part 170.3 • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Example of a “needs improvement” rating: • The inspector failed to verify if the feed manufacturer was required to be registered under the BT Act. • Although the firm met the registration requirements, the inspector failed to verify the status of the firm’s registration. • Did the inspector select appropri
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- Was a copy of the Feed Mill License (FML) and drug registration verified to be active and current?
- Are license keys and active registration required?
