FDA Enforcement: Analysis of Current Trends in Pharmaceutical and Medical Device Industries and Development of Preventive Practices for Continuous Compliance.

摘要

The reason for this study is to analyze the compliance behavior of companies in the pharmaceutical and the medical device industry from 2004 to 2013. Warning letters issued from FDA auditors were examined. This research will evaluate the three major offenders of parts 21 CFR 211 and part 21 CFR 820 and determine the possible root causes of violations. In addition, recommendations were provided to avoid recurrence of the violations. Simple tools like documentation improvement and more advances techniques like Quality by Design (QbD) were among the options give it. Also, location of the companies were studied and was found an increase in the amount of audits realized by the FDA to companies located outside U.S. Was concluded FDA need to improve their work and take more strong measures to assure companies look for solutions to their own problems.