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  The FDA posted 9 warning letters this week, one to a drug product manufacturer, one to a device manufacturer and one to a manufacturer of human tissues/cellular products. We cover these three below. HUMAN CELLS / TISSUES: Human Biologics of Texas / Globus Medical received a warning letter on October 30, 2018, based on […]

From high concentrations of ibuprofen for infants to a metal shard found in a tablet, here are the latest recalls. This post is no longer available. About the Author Barbara W. UngerisGovzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. This post is no longer available.

FDA posted 9 warning letters last week, one of which was issued to a clinical investigator. CLINICAL INVESTIGATOR: Corona Doctors Medical Clinics, Inc (Corona, CA) received a warning letter on November 16, 2018 based on the outcome of an inspection ending June 27, 2018. Deficiencies include but are not limited to the following: Clinical study […]

From children’s allergy medicine to antacid tablets containing metal particles, here are the latest recalls. This post is not longer available.

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. This post is not longer available

FDA posted 22 warning letters, most of them from the Center for Tobacco Products. Among the group were four warning letters for pharma companies and one to a device manufacturer, we cover these five below. DRUGS Mylan Pharmaceuticals (Morgantown, West Virginia) received a warning letter dated November 9, 2018, based on the outcome of an […]

We took a snapshot of the 9 warning letters the FDA sent to food companies last month. Food violations ranged from misbranding products to failure of eliminating rodents. From companies across the country, here they are: Gold Star Distribution, Inc., Minneapolis, MN – violations include but are not limited to:Failed to take effective measures to […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=40] Like this & want more? Sign up to get […]

This week the FDA posted 4 new warning letters: 1 to a cell/tissue product manufacturer1 to a firm for failure to list1 to a compounding pharmacy1 to a device manufacturer CELL AND TISSUE PRODUCTS: StemGenex Biologic Laboratories, LLC (San Diego, CA) received a warning letter on October 31st 2018 based on the outcome of an […]