Common FDA 483 Observations in Visual Inspection of Parenteral Drugs – and How to Avoid Them
Visual inspection of injectable products has always been one of the most challenging parts of sterile manufacturing. Unlike purely instrument-driven quality checks, it relies heavily on human inspectors, their training, and the tools used to support them. Because of this, FDA investigators consistently find gaps during inspections, and many of these observations end up as Form 483s.
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