Category: Supplier Management

Govzilla’s Top 20 Posts of All Time

To serve as a resource for you and your company and to help orient you to the scope of the Govzilla blog, we assembled a list of some of our most useful, relevant, and popular articles of all time.

Read More »

Q1 2020 Roundup: Warning Letters to Food & Dietary Supplement Firms

The first quarter of 2020 is behind us, and with it, a fresh batch of warning letters sent by the FDA to food and dietary supplement companies.

We’ve compiled a snapshot of all of the letters that posted from January through the end of March and organized them by category provided by the FDA for your convenience. In total, 22 warning letters were sent for various infractions, ranging from FSVP violations to Insanitary Conditions.

Read More »

Did COVID-19 Kill Just-in-Time Pharma Supply Chains?

The full impact of the pandemic has yet to be felt, and the intricate and proprietary nature of pharma supply chains prevents an overall industry analysis.  Considering the current reality, is the JIT model now dead or dying in the pharma industry?

Read More »

FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations.  The other two firms manufacture OTC products.  FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.

Read More »

COVID-19 Pandemic and Your GMP Audit Schedule for 2020

A serious concern of many is the security of their supply chain based on its complexity and global nature. We look at the GMP audit program and some options that may be able to help mitigate risk in this area, as well as explain choices made that may be asked during the next health authority inspection.

Read More »

FDA Warning Letters Week of 3/8/2020: BIMO and OTC Products

Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes.  FDA also posted one issued to a drug manufacturer and one to a clinical investigator.  We cover the latter two here.  And, the Cipla warning letter we referenced last week has not been posted yet.

Read More »

Can’t find what you are looking for? Contact us.