# GKS August Warning Letter Wednesday Recap

Source: https://www.globalkeysolutions.net/media/c7908633-f40a-4c9b-97f7-3623d2f0250d
Type: webinar
Published: September 2, 2025
Updated: March 12, 2026
Authors: Dr. Ligia Zubik, Zephaniah Odidika

> Discover key takeaways from GKS’s August Warning Letter Wednesday. Learn how CAPA and FMEA practices reduce FDA 483s and Warning Letters, with insights from experts.

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# GKS August Warning Letter Wednesday Recap

## Summary (TL;DR)

- **Prevention & Correct**: robust CAPAs and a living FMEA are crucial to fewer 483s and Warning Letters.
- **Inspection lifecycle**: Deep coverage of the FDA inspection lifecycle.
- **GKS eLibrary**: Updates on trend citations,mapping keywords & violation codes, and turning insights into leadership-ready KPIs.

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![1756829998899.jpeg](https://storage.googleapis.com/gks-blog-images/blog-images/d0555d45f02a4a2fb2cb65935c0df128.jpeg)

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**Access the recording by viewing our [webinar recap](https://mailchi.mp/8ce82220bec3/subscriber-newsletter-latest-updates-just-for-you-243) and claiming the [Zoom recording or slides](https://mailchi.mp/8ce82220bec3/subscriber-newsletter-latest-updates-just-for-you-243).**

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## Speakers
### Thank you to our Speakers: 

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### [Bill Levinson](https://www.linkedin.com/in/williamalevinson/)

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![1516307014067.jpg](https://storage.googleapis.com/gks-blog-images/blog-images/fa7ebe2ac2e3441ba682853f373ed1cd.jpg)
> “A very large proportion of warning letters arise from failure to take corrective and preventive action.”
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> “Prevention is better than detection.”



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### [Daniel Barreto](https://www.linkedin.com/in/daniel-barreto-021827b4/)

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![1732291102966.jpg](https://storage.googleapis.com/gks-blog-images/blog-images/04065c95d65346528ebf4b8ccd058c47.jpg)
> “Even when companies don't get a 483, that doesn't necessarily mean the company is actually in good shape.”
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> “If you did not provide an adequate response… There is a very high probability that you'll be issued a warning letter.”

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### [Ligia Zubik, Ph.D., ASQ-CQA](https://www.linkedin.com/in/ligia-zubik/)

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![1740453704044.jpg](https://storage.googleapis.com/gks-blog-images/blog-images/419bf1c6d0a446d28399be0bd19b2f8a.jpg)



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## What’s next

- **September Warning Letter Wednesday**, Decoding FDA Warning Letters: Keywords, Analysis & Insight
- [Register Here](https://luma.com/fgucwsan) : [https://luma.com/fgucwsan](https://luma.com/fgucwsan)

- See you at **ISPE Boston Product Show** on Oct 1.

- Follow us on Linked-In: [https://www.linkedin.com/company/globalkeysolutions/](https://www.linkedin.com/company/globalkeysolutions/)

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### Want to be part of future webinars or have questions? 

- **Contact**: hello@globalkeysolutions.net