The sanitary agencies of some countries such as Brazil make public the results of deviations found in the pharmaceutical products, detailing lot and company involved. Is it possible to obtain similar information from the FDA or EMA?
To my best knowledge such detailed, batch related information is not available neither in th USA nor in the EU / EEA and is neither published by th FDA or EMA.
BUT critical and/or major GMP devations detected by FDA or competent EU GMP inspectorates during GMP inspections (EMA herself does not perform GMP inspections, these are conducted by the competent national authorities of the Member States) which lead to assessments of GMP non-compliance are reported i documents accessible by the public. The name of such reports published by USFDA are called Warning Letters accessible by the following link https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm
EU reports about GMP / GDP non-compliances detected during GMP inspections are published EudraGMDP data base http://eudragmdp.ema.europa.eu/inspections/logonGeneralPublic.do
You will find in both data bases a huge number of reports also including world famous companies like Bayer Leverkusen, etc.
Dear Dr. Sonntag,
Thank you very much for your valuable and enlightening reply. I'll check the attached links. Best Regards,
Further to Dr Sonntag's answer, FDA's Office of Regulatory Affairs publishes their objectionable observations, listed on FDA Form 483s, at the FDA website. You can check out https://www.fda.gov/iceci/inspections/ucm250720.htm
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