Manual visual inspection in pharmaceutical manufacturing is a critical process that requires careful risk assessment and mitigation. The FDA and other regulatory agencies emphasize the need for 100% inspection of pharmaceutical products, which can be done using fully automated, manual, or hybrid systems. However, manual visual inspection has its challenges as it relies on the manufacturer's understanding of processes and systems to identify and mitigate risks effectively. Risk mitigation is essential because inadequate inspections can lead to legal consequences for manufacturers. The FDA can legally pursue manufacturers with insufficient inspections, leading to product removal and potential prosecution. Even with 100% inspection, the success rate for these products remains low, with failure rates ranging from 20% to 40%.