Resources

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This post is out of date.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 […]

Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter this week based […]

We’re back after a week off and covering all warning letters from the last two weeks.Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs.There is also one warning letter to a cell therapy manufacturer. Although we do not routinely cover enforcement actions by the […]