Drugs

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Bicooya Cosmetics Ltd. Zhejiang, China (8/11): FDA inspected the firm’s drug manufacturing facility in May and cited it for significant GMP violations with finished pharmaceuticals. For example, the firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin. The firm also failed to clean, maintain, and sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. Additionally, it failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for drug products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm572240.htm

ImprimisRx Folcroft, PA (8/3): FDA inspected the firm in 2016 and cited it for GMP violations involving drug products it produces. For example, FDA found that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions. The agency also found inadequate the firm’s cleaning and disinfecting procedures for work surfaces and utensils used for beta-lactam products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm571790.htm

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