ENFORCEMENT

FDA Warning Letters Week of 4/27/2020: HCT/P

FDA continues their effort to limit the sale of unauthorized electronic nicotine delivery devices by posting ten warning letters last week to firms who target teenagers and other youth. They also continue to issue warning letters to firms that are advertising and distributing unapproved drug products for the prevention and treatment of COVID-19 infection.

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.

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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Cleaning and Cross-Contamination Case Study

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. This first study, presented here, focuses on cleaning and cross-contamination issues with an encapsulator.

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