FDA 483 Warning Letters

White Paper / Q & A Offers Tips on FDA Inspections and the Most Common Reasons Pharmaceutical Companies are Issued a Form FDA-483 or FDA 483 Warning Letters

Validation of manufacturing processes, handling of deviations, and laboratory operations are the top three areas that FDA investigators scrutinize during GMP inspections due to which FDA 483 warning letters are issued, according to a senior regulatory operations officer with the Center for Drug Evaluation and Research (CDER).

Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments