Week of June 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

It was a slow week for warning letters with just two new published.Both were issued to drug manufacturers. DRUGS | Kingston Pharma LLC Kingston Pharma LLC (Massena, NY) received a warning letter based on the outcome of an inspection ending December 10, 2018.The firm manufactures over-the-counter (OTC) drugs. FDA recommends the firm hire consultants to […]

April 2019 | New FDA 483s

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

Medscape | June 6, 2019

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

Week of May 26th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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 […]

Data Integrity Trends in 483s and Warning Letters: Part 3

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 […]

Week of May 19th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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 […]

Week of May 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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 […]

Week of May 5th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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 […]

New York Times | May 13, 2019

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

March 2019 | New FDA 483s

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.
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