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Mislabeling, lack of sterility, sub- and superpotent drugs. Here are the latest recalls. This post is no longer available.

This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products. DRUG: CAO Medical Equipment Co., Ltd. (Hebei, CHINA) received a warning letter on November 30, based on the outcome of an inspection ending July 20, 206. The firm […]

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.

Last week showed a handful of recalls due to the presence of NDEA. Here are the latest recalls. This post is no longer available.

FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer. We cover these three below: Zhejiang Huahai Pharmaceutical (Zhejiang, China) received a warning letter on November 29, 2018 based on the outcome of an inspection ending August 13, 2018. This […]

From lack of sterility to discoloration, here are the latest recalls. This post is no 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 no longer available. About the Author Michael de la Torreis the CEO of FDAzilla.

  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.