Did the inspector demonstrate the ability to distinguish between significant versus insignificant observations and isolated incidents versus trends?
References: • Applicable compliance program referenced in the contract • 21 CFR Part 589, Substances Prohibited from Use in Animal Food or Feed • 21 CFR Part 225, cGMP for Medicated Feeds Examples of a “needs improvement” rating: • The inspector observes minor deficiencies, such as dusty equipment, but overlooks areas where cross contamination of prohibited materials and ruminant feed product might occur. • The inspector identifies record keeping deficiencies in two month old records. The inspector objects to these recorded deficiencies without considering corrective actions have been implemented by the firm and the deficiencies have not been repeated. • During the inspection of a warehouse, the inspector observes products stored away from the wall but fails to see several pallets of pet food are adulterated with moths, bird droppings, and rodent droppings. • Did the inspector review and evaluate the appropriate records and procedures for this establishment’s operation and effectively
