FDA Enforcement News

NASDA and FDA Work Together to Implement the Produce Safety Rule

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.

By | 2018-08-18T01:45:03+00:00 August 16th, 2018|CGMP, FDA Enforcement News, Food, Form FDA 483, FSMA|

The New FDA GMP Inspection Model

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.

Week of July 15th 2018 | FDA Sent These Warning Letters to Pharma Companies

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.