Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...
Govzilla is on the road again! I hope to see you at the International Society for Pharmaceutical Engineering (ISPE) Quality Manufacturing Conference in Arlington, VA from June 4th - 6th. I am excited because this conference will be tackling challenges in quality manufacturing with a special emphasis on the global manufacturing environment. Everyday I speak with our customers from all [...]
We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time.
FDA posted 10 warning letters this week: Several for misbranded drugs 2 in the drug area: 1 for a finished drug manufacturer 1 for a compounding pharmacy Note the FDA ‘requests’ that the firm must respond to. These always provide a roadmap for the type of activities expected of manufacturers who might find themselves with similar challenges. Free learning. [...]
Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA. It can be difficult to navigate new requirements for foreign facilities under FSMA, but [...]
Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week for guidance: The FDA published 6 documents. Nothing from EMA in the areas we follow. WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance. Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA. [...]
In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]
Laws, Regulations, Guidance, and Concept Papers It’s been a slow week all around, perhaps spring breaks and the holidays? Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement A very slow enforcement [...]
Pleasanton, CA | April 9, 2018: FDAzilla, a global leader in FDA intelligence and analytics, announced the addition of Jamie Colgin as GCP Product Manager -- further filling out its team of industry experts to include a GCP and data integrity professional.Jamie, hailing from Moorpark, CA and recipient of the prestigious Charles H. Butler Excellence in Teaching Award, will focus [...]