Category: Inspections

Inadequate Media Fills at a Sterile Manufacturer: CGMP Case Study by FDA National Drug Expert Ileana Barreto-Petit

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

FDA National Drug Expert Ileana Barreto-Petit presents an in-depth analysis of the findings, lessons learned, and how companies can avoid similar findings in regard to a CGMP inspection case study. This case study involves a large, foreign manufacturer of injectable drug products. The product in question is a combination product.

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Champion of Change – 3Cs to Success

Join Govzilla and corporate QA External Engagement Leader, Keynote Speaker, and Leadership Coach, Steve Greer, for an empowering webinar on being a Champion of Change and using the 3Cs to Success in your personal life and organization.  

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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.

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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.

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