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.
Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule (mandated by FSMA) in a letter addressed to NASDA. FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections. They have also been working on alternatives to the traditional 483 inspectional observation form. See the complete run-through of this crucial letter for the food industry.
While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
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.
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.
An efficient summary of all things FDA/GMP related for the week of 7/22/18. A slow week for laws, published docs (5 from the FDA), and warning letters (1 to a compounding pharmacy). See the complete run down here.
FDA posted 6 warning letters this week. Two were issued to firms manufacturing finished pharmaceuticals (bB BioCHem Laboratories Inc. and Claris Injectables Limited). We continue to include the follow-up actions that FDA identified for the firms. Both letters are covered in this post.
Weekly summary of laws, regulations, guidance, and concept papers from the FDA, as well as enforcement actions taken.