Resources

The New York Times: A New Book Argues That Generic Drugs Are Poisoning Us (5/13/19)In her stunning exposé “Bottle of Lies,” Katherine Eban describes a world of generic drug manufacturing rife with corruption and life-threatening misdeeds. Read the full article here. Original story: https://www.nytimes.com/2019/05/13/books/review/bottle-of-lies-katherine-eban.html

In March of 2019, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. This post is no longer available.

Enforcement was light on warning letters this week: one to a device manufacturer, one to a compounding pharmacy and one to a homeopathic drug manufacturer. DEVICE | Surgisil, LLP Surgisil, LLP (Plano, TX) received a warning letter on April 15, 2019 based on the outcome of an inspection ending September 25, 2018. The firm manufactures […]

The Birth Tissue Profiteers Read full article here. The New Yorker article: https://www.newyorker.com/news/news-desk/the-birth-tissue-profiteers

In February of 2019, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. This post is no longer available.

In January of 2019, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. This post is no longer available.

Have you clicked over to the FDA website recently? If so, you saw that the site has a whole new look and feel. After three years in the works, the US Food and Drug Administration (FDA) launched a more customer-centric website at FDA.gov that’s easier to search and view on all browser types and sizes. […]

This was a very light week for warning letters all around with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it below. The other was issued regarding an unapproved new drug that was also misbranded. Looks to be a dietary supplement containing API from approved drug […]

Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues Read the full article here. Original Source: https://www.raps.org/news-and-articles/news-articles/2019/4/scope-of-fda-draft-guidance-on-nonbinding-feedback

When it comes to scanning 483 observations, can a 15-second search replace hours (or weeks) of research and still provide enough data? Yes, and more. Using AI technology and human expertise, the process of researching enforcement and observation trends has become efficient and effective. The Old Way of Researching Combination Products Before the introduction of […]