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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 […]

E-cigarette vaping supplies are almost the sole topic of warning letters posted this week. It seems that FDA is playing catch-up after largely ignoring enforcement in this area. In the areas we cover, there was only one posted warning letter to a fertility clinic, but we also cover two announced warning letters that FDA has not yet […]

It is FDA’s expectation that when observations are identified during an inspection that the firm will take a global view to remediation.This means that gap assessments are performed at all company sites to determine whether the same, or closely related, shortcomings may be found at other sites. Remediation then is also expected to address the […]

We’re back this week after a week with no issued warning letters (week of September 22nd). We include the warning letter issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter. Also, in another first-of-a-kind set of warning letters, the FDA and DEA issued joint warning letters […]

In September, there was one notable Form 483 issued by the FDA to Ipca Laboratories that cites serious deficiencies with the Quality Unit. We look into the details below. We also provide the 59-page response from AveXis regarding the 483 issued to the firm in August. 483s Issued DRUG FIRM: Ipca Laboratories FDA posted a 10-page […]

This post is out of date. Over the years, the FDAzilla blog has published over 650 articles. We’ve acquired many readers since we started writing here in 2010. With these newer followers in mind, FDAzilla has assembled a list of some of our most useful articles. To put together this collection, we considered which posts […]