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FDA Registration Drugs Companies Professional

2 years ago Services Kowloon   893 Hit

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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