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We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of its kind’. One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products […]

FDA posted seven warning letters this week, among which was one to the manufacturer of a dietary supplement and one to a finish pharmaceutical manufacturer. We cover the later below. In addition, FDA continues their enforcement against those who sell flavored liquid tobacco products by issuing four warning letters notifying the companies that forty-four products do not […]

FDA posted five warning letters this week, including several from the Center for Tobacco. None are drug or device GMP warning letters. Now for the interesting part, two warning letters that we cover below were identified as posted on July 23rd. I think this may not be the case because I follow these so closely. So, for any of […]

This week FDA posted three GMP warning letters to drug facilities. We also cover a warning letter to an unapproved, misbranded new drug because of the product category. UNAPPROVED NEW DRUGS | Curaleaf, Inc Curaleaf, Inc (Wakefield, MA) received a warning letter based on evaluation of information on the firm’s website. We generally do not cover warning […]

In June 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.

FDA published three drug warning letters this week, one of which was issued in April. The warning letter to Strides Pharma Science Limited revealed the firm to be shredding GMP documents. Fundamental stuff here. Also, Indoco Remedies announced that their solid oral dosage form plant in Goa, India received a warning letter based on an inspection […]

There were six warning letter postings during this week: three drug warning letters including one regarding Akorn’s site in Somerset, NJ that the company announced a few weeks ago, one to a device manufacturer, one to an IRB, and one to a compounding pharmacy. DRUGS | Akorn, Inc. Akorn, Inc. received a warning letter dated […]

A surprisingly busy week for enforcement considering the federal holiday. Warning letter enforcement includes five drug warning letters published this week, two of which were sent to API re-packagers, and one to a compounding pharmacy. API re-packagers have been a focus recently for actions most notably for failure to identify the original manufacturer on the CoA that […]

Three warning letters were posted this week in the areas we cover: two for drugs and one for device GMP violations. The two drug warning letters are for non-prescription drug products, one over-the-counter (OTC) and one homeopathic located in China and India, respectively. Akorn announced that they received a warning letter for the inspection last summer […]

When it comes to data integrity, audit recommendations, and corrective actions, the correct data analysis is essential for making informed, impactful decisions. If you are interested in learning how to perform data analysis that you can trust and use to make better decisions, you should check out the KENX GMP University Conference in San Diego […]