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In April 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. Post no longer available

‘Scary World’ of Generic Drug Manufacturing, Revealed Read full article here. Medscape Article: ‘Scary World’ of Generic Drug Manufacturing, Revealed

This week’s postings included two to drug manufacturers and three to device manufacturers. FDA’s website update makes warning letters a bit more difficult to monitor because they no longer list the date the letter is posted on the website. The letters continue to be listed, however, in chronological order, so if an older letter is […]

This is the last part in a series of three posts; get up to speed with parts one and two. Now that we’ve reviewed top-level data integrity (DI) trends and what DI keywords the FDA is citing in 483 Observations, let’s look at DI keywords cited in warning letters. Does the FDA cite the same […]

This week’s postings included two to drug manufacturers and three to device manufacturers. FDA’s website update makes warning letters a bit more difficult to monitor because they no longer list the date the letter is posted on the website. The letters continue to be listed, however, in chronological order, so if an older letter is […]

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 […]