FDA Policy/General

Latest FDA Warning Letters

FDA has posted the latest Warning Letters posted the weeks ending 12/25/2020 and 1/1/2021. They can be accessed by clicking on the link following each letter.

Clientele, Sunrise, FL (12/3/2020): FDA inspected the firm in February 2020 and cited significant GMP violations for finished pharmaceuticals. For example, Clientele failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. It also failed to establish adequate written procedures for production and process controls designed to assure that its drug products have the identity, strength, quality, and purity they purport or are represented to possess. To view the letter, click here.

Customceutical Compounding, Phoenix, AZ (8/25/2020): FDA inspected the firm in March 2019 and cited serious deficiencies in its practices for producing sterile drug products. For example, FDA said the company’s drug products were prepared, packed, or held under insanitary conditions. The inspection also observed poor practices during aseptic processing, including a technician failing to sanitize materials prior to placing them into the ISO 5 classified area. To view the letter, click here.

Rowpar Pharmaceuticals, Scottsdale, AZ (12/18/2020): FDA recently reviewed the company’s Web site (www.closys.com) and various social media sites and determined that its CloSYS Oral Spray mouth rinse and similar products are unapproved drugs because they are marketed to mitigate, prevent, treat, diagnose, or cure Covid-19. To view the letter, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome