Resources

Practices to mitigate the spread of COVID-19 have begun. Many people in pharma and biotech companies are working from home, and on-site staff is often severely limited to those performing business-critical activities. A serious concern of many is the security of their supply chain based on its complexity and global nature. We have already seen this play […]

Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes.  FDA also posted one issued to a drug manufacturer and one to a clinical investigator. We cover the latter two below. And, the Cipla warning letter we referenced last week has not been posted yet. […]

This is the second report from the Food and Drug Law Institute (FDLI) conference in December 2019. The first one, published in two parts, covered the Department of Justice (DOJ) activities in the CGMP compliance space during 2019. This article focuses on Center for Drug Evaluation and Research (CDER) activities in 2019. In FY 2019, […]

In February, FDA posted four Form 483s and one untitled letter to compounding/outsourcing facilities.Also posted were three Form 483s to firms in India: Aurobindo, Lupin Limited, and Dr. Reddy’s.We cover these below. And, we reviewed the FDAzilla Store to see which 483s were most-purchased and trending during February. 483s Posted Aurobindo Unit VII The inspection […]

In the last two years, the Department of Justice (DOJ) Consumer Protection Branch (CPB)—responsible for investigating and litigating civil and criminal violations of the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA)—has nearly doubled its number of attorneys and more than tripled its support staff of law clerks, paralegals, and investigators […]

In January, the FDA posted 12 Form 483s and one untitled letter to compounding/outsourcing facilities. We list them below. And, we reviewed the FDAzilla Store to see which 483s were most-purchased and trending during January. 483s to Compounding/Outsourcing Facilities Abilene Nuclear LLC Abilene Nuclear LLC (Abilene, TX) received a form 483 at the end of […]

In November, FDA posted three notable Form 483s to sites of Aurobindo, one of which is a substantial 37 pages. Zydus Cadila received a 23-page, 14-observation Form 483 based on an inspection performed by FDA investigators Thomas Arista and Justin Boyd. [NOTE:Are you interested in learning more about observations with specific industry keywords? Get yourFREE 483 […]

An FDA drug investigator is reporting that a lack of consistency in the interpretation of standard operating procedures (SOPs), in terminology, and in how various types of data are stored, tracked, and trended in drug companies is introducing unneeded risk into their quality management systems. At a PDA Midwest Chapter meeting in Indianapolis in early […]

We took a snapshot of the seven warning letters FDA sent to food and dietary supplement companies that were posted in October. Violations range from misbranding to the presence of Listeria monocytogenes. DIETARY SUPPLEMENTS | Alternative Laboratories Alternative Laboratories (Naples, FL) received a warning letter on September 18, 2019 based on the outcome of an inspection […]

In October, FDA posted three notable Form 483s to sites of Aurobindo, Lupin Limited, and Cipla Limited, all of which are located in India. Aurobindo’s 14-page 483 featuring seven observations is topped by Cipla’s 38-page 483 with 11 observations.Not to be overlooked is FDA’s continued enforcement of Lupin which we provide more information on below. […]