This was an exceptionally light week of only 2 published warning letters, 1 of which was a compounding pharmacy which we cover in this post.
FDA published 13 warning letters this week. Four were sent to device firms located outside the US, and 1 was sent to a compounding pharmacy. We address these in this post along with a GCP untitled letter.
An efficient synthesis of all things FDA/GMP related for the entire month of October 2018. Warning letters, refusals of inspections, new guidance, etc. See the complete run down here.
FDA posted 10 warning letters this week: 8 of them citing unapproved or misbranded new drugs with problematic websites as the source of FDA’s information. Along with this, 1 warning letter was published that was issued to a compounding pharmacy.
We took a snapshot of the 7 warning letters the FDA sent to food companies last month. Food violations ranged from failing to exclude rodents from site to failing to have an HACCP plan.
FDA posted 6 warning letters this week. Among the ones we cover are 1 issued to a pharmaceutical company in South Korea and 1 issued to a clinical trial investigator in California.
What does it even mean to officially respond to a 483 and, better yet, how can a 483 be avoided altogether? The answer is basically split into 3 parts that we dive into in this post.
Every day I work with companies that are looking to find innovative solutions that mitigate compliance risk. I was invited to PDA Midwest's Risk Mitigation & Sterility Assurance Event to share what FDAzilla has found the best practices in supply chain risk mitigation are. In case you missed it, here they are.
FDA posted 6 warning letters this week. One to a device manufacturer which we cover. And 1 for seafood HACCP, 1 for food preparation, and 3 for tobacco.