Resources

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. […]

Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years. These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals. Authorities in the US, EMA, Canada, and Australia, just to name a few, have taken enforcement actions and implemented drug product […]

Enforcement this week includes only two drug warning letters, one of which was issued to a PET drug manufacturer.Firms that are bedeviled by mold findings in both surface and personnel EM would be well served to read this warning letter and the one issued to a sister site last year. FDA’s focus on e-cigarette supplies […]

A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance.This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2018. While the […]

Another busy week on the warning letter enforcement front. Again, like last week, FDA warning letters are led by the Center for Tobacco Products issued to those who sell e-cigarette vaping products. Here we address one warning letter to a device firm, one to a fertility clinic with similar issues to one posted last week, and four […]