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

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FDA 483 Warning Letters Q&A Summary

In this Q&A session, MasterControl copywriter and editor, Cindy Fazzi, interviews Kristen Evans, senior regulatory operations officer at the Office of Compliance of the FDA's Center for Drug Evaluation and Research (CDER). They discuss the following reasons due to which FDA 483 warning letters are issued:

  • Most common reasons why pharmaceutical companies receive a Form FDA-483;
  • Things that investigators look for in terms of training and training control;
  • What investigators look for when evaluating a CAPA system;
  • What companies should do to prepare for a GMP inspection;
  • What companies should do when they receive a FDA 483 warning letters; and
  • Top three areas that FDA investigators are trained to focus on during GMP inspections

How Can MasterControl Help Companies Avoid FDA 483 Warning Letters and Stay Consistently FDA Approved?

With more than a decade of experience in the rigorous FDA environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility to meet every customer's unique needs and saves from being claimed for FDA 483 warning letters.

The MasterControl quality and compliance management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents. It is a form based business processes under a single Web-based platform which electronically can manage all processes which helps in ultimately avoid FDA 483 warning letters. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606).

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