Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations

Regulatory Focus, which requires a subscription found here, contains the following article.

By Alexander Gaffney

The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exhibited by medical device and pharmaceutical manufacturers. Read More...