Did the inspector evaluate conditions, practices, components, and/or labeling that may cause the product to be adulterated or misbranded?
References: • Applicable compliance programs referenced in the contract • GMP inspection guide for non-registered firms • 21 CFR Part 500 or Current Feed Additive Compendium • 21 CFR Part 589, Substances Prohibited from Use in Animal Food or Feed Example of a “needs improvement” rating: • Inspector fails to identify feed containing an unapproved drug combination. • The inspector fails to recognize when a firm’s finished medicated product labeling does not contain a drug declaration. • The inspector fails to note the significance of “back hauling” prohibited materials in a bulk truck used to carry ruminant feeds. • The inspector fails to recognize the addition of a drug during the production of a complete feed and fails to review the feed label. • Did the inspector recognize significant violative conditions or practices, if present, and record findings consistent with federal procedures? References: • Applicable compliance program referenced in the contract • 21 CFR Part 225, cGMP for M
Related Questions
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