Resources

FSMA is Here. How Do You Manage 1,000 Food Suppliers? The advent of the FSMA in the US means that everyone in your supplier network can expect an inspector to knock at some point, underlining the imperative for supplier accountability to compliance teams. Brand revenue and reputation ride on the outcome. This means effectively keeping […]

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016. Two of the guidances, the draft from FDA published in April 2016 and the guidance from EMA posted in August 2016, take a Question and Answer approach. The guidance from […]

We see a lot of people, all throughout the world, purchasing 483s from our FDA 483s store. For example, this month, customers from theUnited States, Italy, Ireland, Canada, and Japan purchased 483s. As a reminder, here are 5 features to look for in a 483. Here are the latest 30 483s purchased from us: FDA483 […]

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from a product containing “hair and a black spider” to management failing to “document laboratory controls.” From pharmaceuticals in Japan, Brazil, and more, here they are (starting with the most recent): Delarange Cosmetics & […]

What industry news have you been reading this month? At FDAzilla, we’ve compiled the most noteworthy articles we’ve come across in the weeks since our last update. This month’s picks include information from two conferences, surprising warning letters abroad and in the US, an explanation QSIT protocol, and stories of both exemplary and reprehensible strategies from companies dealing with in-house deficiencies. Take […]

We see a lot of people, all throughout the world, purchasing 483s from our FDA 483s store. For example, this month, customers from the United States, Germany, Albania, India, and China purchased 483s.  As a reminder, here are 5 features to look for in a 483. Here are the latest 30 483s purchased from us: 1. […]

Glad you asked! Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at [email protected].

We took a snapshot of the 13 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to “maintain written records” to failing to wear “clothing appropriate to protect drug product.” From pharmaceuticals in Brazil, India, China, and 6 US states, here they are (starting with the most recent): […]

We’ve compiled August and September’s mostrelevant, important news foranyone concerned with Pharmaceutical Industry GMP and FDA inspections. Our top 12 picks are listed chronologically by publication date.Happy reading! July 25: After scandal, China begins vaccine inspections nationwide. — Discovery of a blackmarket vaccine ring earlier this year was the impetus for China’s nationwide campaign to inspect vaccine […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> Inspection End Date Company City/Local State/Region Country 1/22/2016 Amgen Manufacturing Limited Juncos PR United States 2/23/2015 Carlos Pantojas San Juan PR United States 9/25/2015 Charles River Laboratories Preclinical Services Reno NV United States 11/2/2015 Comprehensive Telemedicine […]