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FDA Warning Letters

Search FDA warning letters by pharma company, issuing office or the warning letter subject.

Recently published FDA warning letters Over 4,500 records

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What are FDA Warning Letters?
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.


What is the issuing office for a FDA Warning letter?
The issuing office in FDA warning represents the division of the FDA that released the warning letter. A common focus in the pharmaceutical industry is CDER (Center for Drug Evaluation and Research). Although not solely, this is a key division for FDA warning letters regarding drugs


Is there a way to predict an FDA warning letter?
FDA warning letters usually result after a failed response to an inspection with observations. Althought it is not possible to predict warning letters. Following site inspections on Wizmed and watching 438s is a good way to see who many continue to escalate to a warning letter.


If you would rather lookup all data sources at once you can use one search and here are those results for meropenem .

Data Sources 200,000 records

Dailymed - Continuously Updates
OpenFDA - Continuous Updates
Federal Supply Schedule Pricing - Daily
Drugs@FDA - Weekly
Orange Book - Weekly
483s - Weekly
Warning Letters - Weekly
Drug Patents - Weekly
FDA Inspections - Weekly
DMF files - Quarterly
Data dependant on timing of updates to source data. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.