Category: Warning Letters

The Warning Letters category analyzes FDA enforcement actions that reveal critical GMP deficiencies observed during inspections. These letters cite issues such as data integrity, aseptic practices, quality systems, cleaning validation, and product testing, offering lessons with global relevance.

Articles place findings in context, showing how enforcement priorities evolve and what they mean for compliance strategies worldwide. While issued by the FDA, the insights are applicable across markets where regulators align with similar GMP standards.