<span class="archive__title-prefix>Posts Categorized:</span> Enforcement

The week of October 11 saw further Warning Letters issued to manufacturers and distributors of unapproved COVID therapeutics and diagnostics. This summary of Q2 food and dietary supplement Warning Letters includes a listing of such Warning Letters issued in that quarter. On the pharma front, FDA issued an untitled letter to a manufacturer of umbilical […]

Last week, FDA issued a Warning Letter to a drug firm and another to a medical device manufacturer. Lack of of process validation and cleaning validation were some of the deficiencies mentioned in the drug Warning Letter while the medical device Warning Letter emphasized failure to report adverse events. For more details on these Warning […]

The COVID-19 pandemic dominated news headlines in Q2. This naturally seeped into the FDA’s food and dietary supplement Warning Letters for the quarter. FDA issued a number of Warning Letters to dietary supplement firms for statements that certain products could prevent, treat, or cure COVID-19. These are listed below in their own special section. In […]

Last week, FDA issued one Warning Letter to a drug manufacturer and five to compounding pharmacies. The drug manufacturer Warning Letter focused on aseptic processing deficiencies. Interestingly, two of the Warning Letters issued to compounding pharmacies were based on inspections conducted in 2018. Drug Warning and Untitled Letters Panacea Biotec Limited Panacea Biotec Limited (New […]

Last week, FDA issued Warning Letters to two drug companies, one a repackager and the other a manufacturer of sunscreen, and two compounding pharmacies. Both drug Warning Letters cited issues with the Quality Unit while products were recalled from both compounding pharmacies. Drug Warning and Untitled Letters Coupler Enterprises Coupler Enterprises(Warrington, PA) received aWarning Letteron […]

Last week, the FDA posted two warning letters to pharmaceutical firms. One, issued to an OTC manufacturer and API repackager, highlighted product released to the market without a batch record. The other, issued to a homeopathic drug manufacturer, cited a lack of validation in critical areas. Drug Warning and Untitled Letters Kalchem International, Inc. Kalchem […]

It is 2020, do you know what your vendors/suppliers/contract manufacturing organizations are doing? Companies that use contract manufacturing organizations (CMOs) are ultimately responsible for ensuring product quality and compliance with GMPs. Thus, it pays in more ways than one to be aware of recent FDA quality-related citations at CMOs and other vendors. Below is a […]

Last week, the FDA issued two Warning Letters to pharma companies for GMP violations. One cited data integrity failures among other observations at an OTC manufacturer while the second cited a drug repackager for cleaning validation issues. Interestingly, cleaning validation (or lack thereof), was a focus of one of theprevious week’s Warning Letters. Drug Warning […]

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan […]

Another busy week for FDA continuing to issue warning letters to firms who claim to diagnose or treat COVID-19.This week there were also several warning letters issued for failure to comply with the food foreign supplier verification program, the most recent Tobacco Control Act, and food production GMPs. Among the areas we follow, there were […]