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In May 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

This was a busy week in contrast to the past two weeks in terms of posted warning letters. Seven drug warning letters and one device warning letter were posted this week. DRUGS | Glint Cosmetics Pvt. Ltd Glint Cosmetics Pvt. Ltd (Maharashtra, India) received a warning letter on May 31, 2019 based on the outcome […]

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 […]

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 […]