warning letter


Also found in: Acronyms.

warning letter

A written communication from the FDA notifying an individual or enterprise that it considers one or more of its products, practices, processes or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice.
Mentioned in ?
References in periodicals archive ?
FIGURE 1 Types of Letters by Years Frequency Year Warning Letter Untitled Letter Linear (Warning Letter) 2005 16 13 2006 14 8 2007 10 9 2008 11 10 2009 14 27 2010 14 38 2011 5 26 2012 3 25 2013 3 21 2014 0 9 2015 2 7 2016 3 8 Note: Table made from bar graph.
Pine Berry Remodeling received a warning letter and was fined $1,000 for excavating without a Pennsylvania One Call System ticket or obtaining a township permit for a May project in Penn Township, Lancaster County.
The spokesperson went on to add that the warning letters could be just the start.
When FDA issues a Warning Letter, generally it is because they have some concerns over the firm's response to one or more 483s.
The warning letter, issued by the FDA's Center for Devices and Radiological Health, focused on Dako's quality management processes for complaint handling, corrective and preventive actions, statistical techniques and process validation.
This communication follows the agency's reinspection of the facility in February 2014 to complete its evaluation of corrective actions taken in response to the warning letter, and it resolves all issues that were raised by the FDA in February 2012 and all subsequent communications.
In its warning letter, the Health Ministry also stated that they are unaffiliated with the research company's project.
Augustus said he was unaware of the warning letter, which came eight months after he left the Children's Defense Fund.
The USFDA has issued warning letters to several other global pharmaceutical giants, showing an alarming growth in the violation of Current Good Manufacturing Practices ( cGMP).
On July 18, Intuitive disclosed that an FDA warning letter had been received and cut its 2013 revenue forecast by more than hall saying sales growth may range from unchanged to 7 percent.
The decision in Sabel is driven by the fact that the warning letter was authored by Dr.
Regardless of whether the recent surge in warning letter issuances has led to a shortage of medications, those within industries regulated by FDA should take note of this trend and what can be learned from such occurrences.