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Susan Haigney is managing editor of BioPharm International, email@example.com.
FDA Updates List of Warning Letters
FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research (CDER).
Improper training and a lack of written procedures were among some of the citation trends. Deviations from cGMP in the manufacture of APIs cited by CDER include:
Violations in regulations for finished pharmaceuticals include:
Warning Letters issued by the Office of Prescription Drug Promotion in 2012 cite drug manufacturing companies for overstating efficacy of products, misbranding, presenting misleading information, making unsubstantiated claims, and omitting risk information from advertising materials in a variety of media outlets.
A complete list of FDA-issued Warning Letters can be found at FDA.gov.