Drugs

CGMP, Other Violations at Bulletproof 360

An 8/12-9/6/19 FDA inspection at Bulletproof 360, Seattle, WA, found serious violations of current good manufacturing practice (CGMP) regulations for dietary supplements, as well as other violations. A 3/20 Warning Letter says the agency determined that some of the firm’s supplements are considered to be unapproved new drugs that are also misbranded.

Specific CGMP violations listed were:

failing to establish component specifications for each component used in the manufacture of a dietary supplement; and
failing to establish product specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of the dietary supplement to ensure its quality.

FDA says it was unable to evaluate the adequacy of the firm’s responses to the FDA-483 inspection observations because it did not provide sufficient information and documentation.

Bulletproof was told to take prompt action to correct the violations and to respond with a list of specific steps taken with documentation of each step and a timetable for completing the actions.

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