This week the FDA published 4 warning letters (3 to seafood companies and 1 to an API manufacturer - Les Produits Chimiques B.G.R. Inc). We cover the latter below.
We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from failing to implement sanitation controls to failing to have an HACCP plan.
“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”
The FDA posted 9 warning letters this week including 1 to a device manufacturer, 1 each to an API manufacturer and compounding pharmacy, and, finally, 2 to finished dosage form manufacturers.
An efficient summary of all things FDA/GMP related for the week of 7/29/18. FDA, EMA, etc. have picked up the pace for laws/published docs. Same with warning letters (5 issued). See the complete run down here.
“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?
A really slow FDA week -- 1 letter to a compounding pharmacy (Gipsco Investment Corp) and 1 to a firm for misbranded unapproved drug marketing. We cover the compounding pharmacy letter consistent with past practices.
When the FDA notifies you of an upcoming inspection, sometimes you only have minutes to prepare. You need information, and you need it fast. Most companies start with a Google search or call their colleagues to get information about their inspector. But with FDAzilla, you have more than anecdotes. You have real statistics. In this post, we will walk through an FDAzilla inspector profile — a snapshot of the inspection and citation history of one of the 4,000+ FDA inspectors in our database.
GMP enforcement citing data governance and data integrity has not diminished — expanding both the number of warning letters and their geographic distribution. We discuss the addition of 3 new focus areas and what our GMP expert is watching out for in 2018.