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Enforcement included five warning letters to either homeopathic or OTC firms continuing the FDA’s focus in this area that we saw begin in 2017 and really ramp up in 2018. Fundamental GMPs seem to be missing. It appears that FDA has implemented enforcement against both the product owner and the contract manufacturer in this group. This, in my […]

Enforcement was light this week, including a single warning letter to a drug manufacturer in France. We cover it below. DRUG | Laboratoires Clarins Laboratoires Clarins (Pontoise, France) received a warning letter on April 23, 2019 based on the outcome of an inspection ending September 21, 2018. FDA points the firm to the FDA guidance on […]

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 […]