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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Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues Read the full article here.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 […]

This week FDA posted 11 warning letters to dietary supplement manufacturers, one issued regarding tobacco, two to pharma firms, and one to a compounding pharmacy. We cover the last three here. DRUGS | Luen Fook Medicine Sdn. Bhd. Luen Fook Medicine Sdn. Bhd. (Singapore) received a warning letter on April 4, 2019 based on the outcome […]

Govzilla and FOI Services announced Tuesday, April 16th, 2019 the beginning of their official partnership that integrates FOI Services’ unique and vast dataset with Govzilla’s innovative analytics tools to help solve regulatory intelligence problems. FDA regulated industries’ need for immediate access to enforcement documents is growing as more companies expand their markets and supply chains […]

Enforcement was slow this week. No drug or medical device GMP warning letters were issued except for two to compounding pharmacies, a rarity. We cover those two here. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago. COMPOUNDING PHARMACY | Apollo Care LLC Apollo Care LLC […]