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How to Avoid FDA Warning Letters

As Editor of The Medicine Maker, I have to stay on top of pharma industry news and announcements. And one of my (in-no-way guilty) pleasures is patrolling the FDA’s Warning Letter Archives. Perhaps unsurprisingly, the FDA sends out Warning Letters all of the time – more than 190 have been sent out in the first half of 2022 alone. Some Letters tackle what appear to be genuine errors or oversights, others rather politely draw attention to issues that defy common sense and even human decency – particularly when unapproved products are being marketed to vulnerable patients.

Here, I present a selection of Warning Letters that forms a short guide of what not to do… 

Don’t advertise misbranded or unapproved drug products

Selling unapproved and/or misbranded drug products is one way to get an FDA Warning Letter. was caught offering drug products for sale to “mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases such as malaria.” A US-based company called CofixRx also received a Warning Letter for selling products against COVID-19. For example, the company claimed that its nasal spray “DESTROYS SARS-CoV-2 and other COLD & FLU viruses in 15 seconds.”

Don’t refuse an inspection

Glicerinas Industriales in Mexico received a Warning Letter for refusing an inspection. Inspections are a fact of life in the pharma industry and it’s not a good look if you refuse one. Due to the refusal, the FDA has classified the company’s products as adulterated. The letter states, “Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.”

Keep things clean

Cleaning is essential in the pharma industry. New Vitalis – a US compounding pharmacy that advertises itself as “the Midwest’s leading source for compounded pharmaceuticals” – received a Warning Letter because sterile drug products were being “prepared, packed or held in unsanitary conditions,” with inspectors noting vermin near to the production area, visibly dirty surfaces, debris on floor, black residue on the cleanroom floor, improper gowning procedures, and more.

The inspection took place in August 2021. In September 2021, the pharmacy recalled certain products due to lack of sterility assurance and voluntarily ceased sterile compounding.

Follow cGMP

Brigham and Women’s Hospital received a Warning Letter for lack of cGMP. PET drug products for parenteral administration were being produced in an unsuitable facility that was not “adequately designed or controlled for aseptic processing.” The letter also mentions water leaking into the raw material storage area and technical corridor. Oh – and environmental monitoring turning up fungal species in the ISO 5 classified environments. The hospital was also not taking corrective action when batches fell out of specification.

Miami University Department of Chemistry and Biochemistry’s contract testing laboratory has also suffered cGMP issues. The FDA identified data integrity issues, including uncontrolled folders, unvalidated software, no documentation for sample reprocessing, among other issues; no quality system for oversight of laboratory operations; and a failure to train staff. The agency recommended that the university hire a consultant to assist with cGMP requirements.

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About the Author
Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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