Resources

No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere that focused on aseptic processing and data integrity. Akorn, Inc. (Decatur, IL) received a warning letter on January 4, 2019 based on the outcome of an inspection at their site ending May 16, 2018. […]

It’s been a light couple of weeks due to the partial government shutdown. Here are the latest recalls. This post is no longer available.

Enforcement: Recalls:Classified recalls from 21 firms, Unclassified recalls from 13 firmsClass II and III recallsImport Alerts:A limited number of import alerts from Israel and China Warning Letters:Drug Manufacturers:  4 warning lettersHuman Cells/Tissues: 2 warning lettersCompounding Pharmacies:  1 warning letter for an inspection ending in 2016 (not a typo)Device Firms: 1 warning letter483s:3 483s sent, one to a Phizer […]

The House, the Senate, and the President of the United States failed to reach an agreement on a short-term spending bill to extend funding for seven federal departments including the Department of Health and Human Services that funds the FDA. As a result, the FDA has furloughed 41% of its staff—some 7,000+ employees in total. […]

We took a snapshot of the 2 warning letters the FDA sent to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella. Avalon Packaging, American Fork, UT – Violations were grouped into three categories: Pathogen Findings, CGMP Violations, and New Dietary Ingredient.Pathogen Findings:FDA collected three raw kratom samples that were to […]

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 […]