Most Frequent Violations of FDA Regulations: Unapproved New Drugs Misbranded New Drugs Misbranding of an Investigational New Drug Failure to properly maintain equipment used in the manufacture of API Omission of Risk Information Omission of Material Fact Failure to Submit Under Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) Failure to update drug listing files to reflect discontinuance of drug products Adulterated Dietary Supplements Misbranded Dietary Supplements Failure to conduct Hazard Analysis and Risk-Based Preventive Controls Failure to maintain Current Good Manufacturing Practices ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 www.itbhdg.com www.m.itbhdg.com www.fda.itbhdg.com
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